CLASS II Device recall · Reported 18 Jul 2012 · FDA Enforcement Report
Sara Plus Mobile Patient Lifter recalled by Arjo
Arjo is recalling Sara Plus Mobile Patient Lifter, distributed nationwide in the US. The recall was initiated on 29 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1949-2012
- FDA event ID
- 62116
- Recalling firm
- Arjo, Addison, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2012
- FDA classified
- 6 Jul 2012
- Reported
- 18 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 29 Jun 2012 | Recall initiated by company | |
| 6 Jul 2012 | Classified by FDA | +7 days |
| 18 Jul 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
Questions about this recall
Is Sara Plus Mobile Patient Lifter recalled?
Yes. Arjo recalled Sara Plus Mobile Patient Lifter on 29 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-1949-2012.
Why was it recalled?
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Which lots are affected?
Models HEP0001-US, serial numbers SPSN0808U285, PN1010U507, PN1102U092, PN1102U110, SPSN0905U022, SPSN0907U048, SPSN0909U091, SPSN0605U388, SPSN0810U506, PN1102U093, PN1102U101, PN1102U112, PN1104U199, PN1104U201, PN1104U203, PN1104U214, PN1104U215, PN1104U216, PN1104U217, PN1104U220, PN1104U224, PN1104U225, PN1106U365, SPSN0804U387, SPSN0605U421, SPSN0605U423, SPSN0605U425, SPSN0605U431, SPSN0605U432, SPSN0605U440, SPSN0605U199, SPSN0605U365, SPSN0901U033, SPSN0605U206, SPSN0605U214, SPSN0605U217, SPSN0605U220, SPSN0801U071, SPSN0801U072, SPSN0707U484, SPSN0709U689, SPSN0709U692, SPSN0709U693, SPSN0710U842, P0129686, P0123033, SPSN0808U284, P0120989, SPSN0703U140, P0116656, SPSN0605U241, SPSN0605U242, SPSN0605U243, SPSN0605U244, SPSN0605U245, SPSN0605U246, SPSN0605U247, SPSN0605U248, SPSN0605U249, SPSN0605U350, SPSN0605U351, SPSN0605U352, SPSN0605U353, SPSN0808U199, PN1009U430, PN1008U393, SPSN0904U419, SPSN0906U038, SPSN0605U138, SPSN0605U140, SPSN0605U145, SPSN0605U148, SPSN0605U153, SPSN0605U414, SPSN0605U416, SPSN0605U420, P0121743, SPNS0706U431, SPNS0706U433, SPNS0706U443, SPNS0706U445, SPSN0605U412, SPSN0605U442, SPSN0605U447, SPSN0605U451, SPSN0605U461, SPSN0605U469, SPSN0605U473, SPSN0605U480, SPSN0704U296, SPSN0704U297, SPSN0704U300, SPSN0704U301, SPSN0709U767, SPSN 907U052, SPSN0705U398, PN1101U039, P0122276, SPSN0605U355, SPSN0605U356, SPSN0605U373, SPSN0605U375, PN1104U219, SPSN0605U362, SPSN0605U189, SPSN0605U233, SPSN0605U212, SPSN0605U237, SPSN0703U123, SPSN0703U129, SPSN0707U456, SPSN0707U466, SPSN0707U467, SPSN0707U468, SPSN0707U470, SPSN0707U475, SPSN0707U480, SPSN0707U483, SPSN0707U485, SPSN0710U878, SPSN0710U882, SPSN0904U415, SPSN0907U040, SPSN0907U060, SPSN0908U031, SPSN0605U378, SPSN0810U502, SPSN0801U073, SPSN0605U226, PN1010U517, SPSN0904U437, SPSN0904U442, SPSN0904U447, SPSN0904U453, SPSN0906U004, SPSN0906U007, SPSN0906U009, SPSN0906U012, SPSN0906U013, SPSN0906U014, SPSN0906U016, SPSN0803U350, PN1101U049, PN1101U054, PN1101U056, PN1106U379, SPSN0605U407, SPSN0605U410, SPSN0605U415, SPSN0901U029, SPSN0901U030, SPSN0901U036, SPSN0901U037, SPSN0901U041, SPSNO605U178, SPSNO605U179, SPSN0703U127, P0130066, SPSN0605U134, SPSN0605U149, SPSN0605U150, SPSN0902U218, SPSN0904U423, SPSN0705U395, SPSN0901U107, SPSN0901U023, SPSN0901U039, PN1104U242, SPSN0901U050, SPSN0808U164, SPSN0907U029, SPSN0703U198, SPSNO605U167, SPSN0605U411, PN1104U247, PN1105U293, SPSN0605U210, SPSN0807U145, SPSN0808U156, SPSN0808U163, SPSN0808U165, SPSN0808U166, PN1006U301, SPSN0907U038, SPSN0605U471, SPSN0605U418, SPSN0605U208, PN1105U306, SPSN0811U602, SPSN0909U088, SPSN0702U046, SPSN0702U047, SPSN0702U048, SPSN0702U052, SPSN0702U054, SPSN0702U055, SPSN0804U390, SPSN0901U040, P0130065, SPSN0705U393, SPSN0707U473, SPSN0710U849, PN1104U252, P0120986, SPSN0810U497, PN1010U510, P0116659, SPSN0904U379, SPSN0904U380, SPSN0904U392, SPSN0904U394, SPSN0904U395, PN1010U508, SPSN0810U408, SPSN0810U419, SPSN0605U177, SPSN0808U283, SPSNO605U166, SPSN0803U343, SPNS0706U437, SPNS0706U447, SPSN0605U390, PN1008U381, SPSN0605U370, SPSN0703U125, SPSN0805U036, SPSN0805U038, SPSNO605U168, SPSNO605U181, SPSNO605U184, SPSN0605U234, SPSN0902U208, SPSN0605U401, SPSN0707U478, SPSN0605U221, PN1105U312, PN1008U382, PN1106U361, SPSN0710U844, SPSN0809U371, SPSN0808U280, SPSN0709U762, SPSN0801U064, SPSN0803U346, SPSN0904U393, SPSN0605U400, SPSN0806U075, SPSN0806U076, SPSN0806U077, SPSN0806U079, SPSN0707U481, SPSN0905U019, P0109559, P0109642, SPSN0605U474, SPSN0709U694, PO106458, SPSN0709U763, SPSN0901U112, SPSN0605U384, SPSN0810U423, SPSN0605U205, SPSN0804U377, SPSN0605U194, SPSN0904U388, SPSN0709U688, SPSN0710U883, SPSN0710U896, SPSN0810U512, SPSN0904U429, SPSN0605U462, SPSN0605U385, SPSN0605U387, SPSN0605U231, SPSN0605U235, PN1009U439, SPSN0801U132, SPSN0801U135, SPSN0801U136, SPSN0904U439, SPSN0904U443, PN1101U038, PN1102U079, PN1102U094, PN1102U105, PN1104U196, SPSN0805U037, SPSN0707U461, SPSN0605U419, PN1105U305, SPSN0804U392, SPSN0904U450, SPSN0904U452, SPSN0801U134, SPSN0801U140, SPSN0807U131, SPSN0807U132, SPSN0807U133, SPSN0807U134, PSN0807U135, SPSN0807U136, SPSN0807U137, SPSN0807U138, SPSN0807U139, SPSN0807U140, SPSN0703U195, SPSN0707U474, SPSN0809U370, P0122277, PN1102U107, SPSN0710U879, SPSN0801U063, PN1102U082, SPSN0605U380, PN1009U428, PN1009U443, PN1010U502, PN1010U509, PN1010U511, PN1105U304, SPSN0908U028, SPNS0706U440, SPSN0605U376, SPSN0605U424, SPSN0605U426, SPSN0605U428, SPSN0605U436, SPSN0605U455, SPSN0605U456, SPSN0605U457, SPSN0605U477, SPSN0605U224, P0109558, P0109641, SPSN0710U831, PN1105U292, SPSN0803U345, SPSN0803U349, P0119635, SPSN0901U051, SPSN0901U106, SPSN0901U111, SPSN0901U115, SPSN0902U210, SPSN0902U211, SPSN0902U215, SPSN0902U216, SPSN0605U467, SPSN0808U157, SPSN0808U159, PN1008U375, PN1008U379, SPSN0605U448, SPSN0801U070, SPNS0706U442, SPSN0605U463, SPSN0605U470, SPSN0710U885, SPSN0803U347, PN1105U296, PN1106U373, SPSN0605U193, SPSN0907U032, SPSN0909U089, SPSN0909U096, SPSN0605U188, SPSN0605U229, SPSN0605U363, SPSN0605U366, SPSN0605U367, SPNS0706U432, SPSN0705U396, SPSN0705U348, SPSN0705U350, SPSN0705U392, SPNS0706U444, SPSN0904U409, SPSN0904U417, SPSN0904U422, SPSN0904U428, SPSN0905U014, SPSN0908U034, P0127101, SPSN0906U008, SPSN0901U118, SPSN0605U429, SPSN0605U437, SPSN0605U187, SPSN0605U368, SPSN0605U371, PN1008U389, SPSN0904U420, SPSN0909U090, SPSN0708U543, SPSN0605U191, PN1105U294, SPSN0605U408, SPSN0707U464, SPSN0605U209, SPSN0907U035, SPSN0907U037, SPSN0907U041, SPNS0706U435, SPNS0706U448, SPSN0810U511, SPSN0605U483, PN1102U099, SPSN0907U033, SPSN0905U025, SPSN0906U036, PN1102U081, PN1102U104, PN1102U113, PN1102U114, SPSN0809U327, P0109646, PN1009U433, PN1104U239, PN1104U248, PN1104U249, PN1104U260, SPSN0906U042, PN1106U375, P0116660, P0116661, P0117197, P0119638, P0120178, P0120179, P0120259, P0120260, P0120261, P0120550, P0120551, P0120988, P0127341, SPSN0703U138, SPSN0901U028, SPSN0901U031, SPSN0906U011, SPSN0808U201, SPSN0810U496, SPSN0811U606, SPSN0811U609, SPSN0803U352, SPSN0809U321, SPSN0605U476, SPSN0605U216, SPSN0709U761, SPSN0709U764, SPSN0808U282, SPSN0810U495, SPSN0710U829, SPSN0710U830, SPSN0710U833, SPSN0710U834, SPSN0710U835, SPSN0710U836, SPSN0710U837, SPSN0710U838, SPSN0710U840, P0128151, SPSN0810U421, P0109643, P0109645, P0109648, P0111933, P0111935, PN1106U374, SPSN0901U116, SPSN0809U372, SPSN0703U134, SPSN0612U949, SPSN0904U383, SPSN0605U225, SPSN0808U196, SPSN0705U345, SPSN0705U347, SPSN0705U349, SPSN0901U032, PN1105U298, PN1105U299, SPSN0605U459, SPSN0605U482, SPSN0904U375, SPSN0907U020, SPSN0907U043, P0129906, PN1008U394, PN1102U077, PN1102U108, SPSN0805U040, SPSN0707U457, SPSN0707U458, SPSN0707U459, SPSN0707U460, SPSN0808U286, SPSN0707U469, PN1104U240, P0106457, SPSN0703U124, SPSN0605U211, PN1105U309, SPSN0809U373, SPSN0810U559, SPSN0702U053, PN1102U109, PN1104U223, SPSN0605U441, SPSN0605U240, PN1010U512, PN1010U516, P0106454, SPSN0804U385, SPSN0902U212, SPSN0904U382, SPSN0605U202, PN1105U291, SPSN0605U361, SPSN0605U223, SPSN0904U440, SPSN0605U406, SPSN0705U397, SPSN0708U540, SPSN0708U541, SPSN0708U545, SPSN0708U546, SPSN0708U547, SPSN0708U548, SPSN0708U549, SPSN0704U294, PN1010U522, SPSN0605U435, SPSN0703U142, PN1101U036, PN1101U047, PN1101U050, PN1101U055, SPSN0907U059, SPSN0803U342, P0121744, P0122278, SPSN0807U148, SPSN0807U149, SPSN0605U466, SPSN0901U024, SPSN0904U432, SPSN0907U061, SPSN0703U128, SPSN0707U465, PN1101U009, SPSN0801U066, SPSN0605U219, SPSN0907U022, SPSN0907U049, P0109647, SPSN0803U344, SPSN0809U375, SPSN0907U039, SPSN0710U839, SPSN0804U378, SPSN0810U508, PN1008U384, SPSN0907U023, SPSN0907U054, SPSN0908U027, SPSN0605U192, SPSN0605U203, SPSN0906U039, SPSN0906U043, SPSN0907U025, SPSN0907U026, SPSN0907U047, SPSN0805U045, SPSN0808U198, SPSN0808U200, SPSN0808U203, SPSN0808U206, SPSN0808U276, SPSN0808U278, SPSN0904U378, SPSN0904U389, SPSN0807U147, SPSN0605U391, SPSN0904U376, SPNS0706U438, SPSN0710U832, PN1102U103, PN1102U106, PN1104U226, SPSN0907U058, SPSN0907U062, SPSN0907U063, SPSN0605U146, SPSN0907U044, SPSN0808U279, SPSN0804U379, SPSN0605U452, SPSN0907U050, P0106453, SPSN0605U439, SPSN0605U443, SPSN0605U444, SPSN0605U445, SPSN0605U446, SPSN0605U450, SPSN0709U695, PN1104U200, SPSN0710U894, P0116654, SPSN0907U056, SPSN0907U065, SPSN0909U095, P0123030, SPSN0804U389, SPSN0805U042, SPSN0605U222, SPSN0605U232, SPSN0605U238, PN1104U253, SPSN0907U021, PN1008U374, PN1008U380, PN1010U505, PN1104U258, SPSN0904U386, PSN0904U418, SPSN0905U020, SPSN0905U026, PN1009U425, PN1009U426, PN1009U427, PN1009U429, PN1010U506, PN1105U295, PN1010U503, SPSN0707U463, SPSN0901U038, SPSN0904U433, SPSN0907U034, SPSN0907U045, SPSN0605U382, SPSN0801U139, PN1106U369, SPSN0901U022, SPSN0901U043, SPSN0908U029, SPSN0803U351, SPSN0605U357, SPSN0605U358, SPSN0605U359, SPSN0605U360, PN1009U434, PN1009U437, PN1009U440, SPSN0605U377, SPSN0605U386, SPSN0804U384, P0119640, P0120262, P0123031, P0130067, SPSN0810U558, SPSN0909U092, SPSN0909U094, SPSN0605U170, SPSN0605U182, SPSN0904U381, SPSN0808U207, SPSN0612U941, SPSN0612U942, SPSN0612U943, SPSN0612U944, SPSN0612U945, SPSN0612U946, SPSN0612U948, SPSN0612U950, SPSN0701U975, SPSN0701U978, SPSN0701U979, SPSN0701U980, SPSN0701U981, SPSN0701U982, SPSN0701U983, SPSN0807U150, SPSN0810U562, P0106451, SPSN0707U471, SPSN0707U472, SPSN0707U477, PN1104U221, SPSN0605U215, SPSN0605U186, P0106455, SPSN0805U041, SPSN0703U196, SPSN0703U197, SPSN0703U199, SPSN0704U298, SPSN0809U325, SPSN0811U603, SPSN0605U393, SPSN0701U976, SPSN0605U198, PN1009U442, SPSN0605U403, SPSN0605U404, SPSN0605U405, PN1104U197, PN1104U202, SPSN0811U605, SPSN0811U608, SPSN0904U446, SPSN0605U417, PN1105U311, PN1105U313, SPSN0605U398, SPSN0809U324, SPSN0809U368, SPSN0809U377, SPSN0809U378, SPSN0810U409, SPSN0710U848, P0127932, PN1010U514, P0129905, P0129910, SPSN0605U399, SPSN0605U464, SPSN0605U465, SPSN0904U431, SPSN0808U161, SPSN0808U162, SPSN0803U341, SPSN0709U686, PN1006U302, SPSN0801U065, SPSN0801U068, SPSN0801U069, SPSN0801U131, SPSN0801U133, PN1008U373, P0120549, SPSN0904U397, SPSN0905U015, SPSN0703U200, SPSN0703U201, SPSN0703U202, SPSN0703U203, SPSN0804U383, SPSN0908U035, SPSN0605U227, SPSN0906U037, SPSN0901U110, PN1102U063, PN1010U501, PN1102U074, PN1102U095, PN1102U098, SPSN0605U228, SPSN0605U458, P0130064, PN1008U387, SPSN0605U173, PN1104U198, PN1008U388, PN1008U391, SPSN0906U006, PN1010U521, PN1010U523, PN1008U385, SPSN0808U277, PN1104U257, SPSN0703U130, SPSN0703U131, SPSN0810U406, SPSN0807U129, SPSN0904U396, PN1101U035, SPSN0808U204, SPSN0907U057, PN1010U518, SPSN0809U323, SPSN0809U326, SPSN0804U393, SPSN0605U392, SPSN0605U175, SPSN0707U462, SPSN0807U151, SPSN0901U047, PN1008U392, SPSN0901U114, SPSN0904U377, SPSN0904U384, SPSN0904U421, SPSN0804U381, SPSN0804U382, SPSN0605U434, PN1102U067, PN1106U381, SPSN0605U383, SPSN0605U394, SPSN0605U372, SPSN0605U396, SPSN0605U397, SPSN0808U158, SPSN0605U433, PN1101U007, PN1101U008, PN1101U010, PN1101U011, PN1101U012, PN1101U013, PN1008U378, PN1006U298, PN1006U299, PN1006U300, PN1006U303, PN1006U304, PN1006U305, PN1006U306, SPSN0904U412, SPSN0907U027, SPSN0907U028, P0109644, PN1008U386, P0127933, SPSN0605U395, SPSN0704U295, SPSN0810U501, SPSN0808U205, SPSN0808U208, PN1104U241, SPSN0605U460, SPSN0809U367, SPSN0810U405, SPSN0810U412, SPSN0810U418, SPSN0810U422, SPSN0807U130, SPNS0706U449, SPSN0809U322, SPSN0605U413, SPSN0901U027, PN1010U504, SPSN0907U064, SPSN0904U391, SPSN0901U025, P0130069, SPSN0905U018, SPSNO605U165, SPSN0605U174, SPSN0906U044, P0129911, PN1105U297, PN1106U380, SPSN0701U974, PN1102U102, P0117196, P0129683, SPSN0605U236, PN1101U014, SPSN0605U422, SPSN0605U472, SPSN0904U414, SPNS0706U434, SPSN0703U133, PN1105U301, PN1101U037, PN1104U243, PN1104U244, PN1105U302, PN1106U368, PN1106U382, SPSN0605U369, SPSN0605U427, SPSN0605U453, SPSN0605U454, SPSN0605U135, SPSN0605U139, SPSN0605U141, SPSN0605U239, SPSN0605U484, SPSN0705U399, SPSN0904U444, SPSN0810U499, SPSN0810U503, SPSN0810U505, SPSN0810U507, PN1102U100, SPSN0901U113, SPSN0703U194, SPSN0804U380, SPSN0708U542, SPSN0605U172, SPSN0605U213, SPSN0810U498, SPSN0810U509, SPSN0810U560, SPSN0811U604, SPSN0811U607, PN1106U364, PN1101U052, SPSN0808U202, P0124188, P0127929, PN1008U383, PN1101U053, SPSN0805U044, SPNS0706U439, SPSN0901U035, P0128150, PN1008U372, SPSN0707U476, SPSN0702U049, SPSN0702U050, SPSN0702U051, SPSN0703U122, SPSN0703U132, SPSN0703U135, SPSN0703U139, SPSN0801U074, SPSN0907U042, SPSN0605U449, SPSN0605U475, SPSN0709U691, SPSN0801U067, SPSN0904U438, SPSN0904U441, SPSN0810U416, PN1105U300, SPSN0605U207, SPSN0703U137, SPSN0705U394, SPSN0708U544, SPSN0803U353, SPSN0803U354, SPSN0902U213, SPSN0901U026, P0127928, SPSN0907U051, SPSN0807U144, SPSN0605U409, SPSN0904U426, SPSN0808U160, PN1105U307, PN1105U310, PN1106U360, PN1106U370, PN1106U371, SPSN0904U451, PN1009U431, SPSN0605U379, SPSN0809U376, SPSN0809U379, SPSN0705U390, SPSN0801U138, SPSN0605U468, SPSN0904U410, SPSN0904U425, SPSN0905U016, SPSN0907U036, SPSN0804U388, SPSN0709U687, SPSN0806U071, SPSN0806U072, SPSN0806U073, SPSN0806U074, SPSN0806U078, P0106452, P0111931, P0111934, P0111936, P0111937, P0111938, P0111940, P0116500, P0116657, PN1105U308, PN1106U362, PN1106U372, PN1106U377, PN1106U378, PSN0605U190, SPSN0605U201, SPSN0808U197, SPSN0605U183, SPSN0904U385, SPSN0904U390, SPSN0907U053, SPSN0905U023, SPSN0905U027, SPSN0605U364, SPNS0706U436, SPNS0706U441, SPSN0710U828, PN1106U376, SPSN0710U846, SPSN0704U293, SPSN0705U341, SPSN0705U342, SPSN0605U354, SPSN0710U874, SPSN0710U877, SPSN0710U887, SPSN0710U889, SPSN0710U891, SPSN0710U892, SPSN0710U895, SPSN0810U556, SPSN0810U557, SPSN0810U561, SPSN0811U610, PN1104U245, PN1104U250, PN1104U251, SPSN0710U847, SPSN0710U850, SPSN0805U039, SPSN0805U043, PN1010U520, SPSN0605U381, SPSN0904U434, SPSN0804U386, SPSN0704U292, PN1101U042, PN1101U043, PN1101U044, PN1101U048, PN1102U068, PN1102U073, SPSN0605U389, P0116658, SPSN0612U947, SPSN0904U427, SPSN0906U041, SPSN0807U141, SPSN0807U142, SPSN0807U143, SPSN0807U146, SPSN0905U017, SPSN0605U136, SPSN0605U142, SPSN0605U151, SPSN0605U152, PN1104U222, PN1106U363, PN1106U366, PN1106U367, SPSN0605U430, SPSN0904U435, SPSN0710U845, SPSN0709U765, SPSN0709U768, SPSN0709U769, SPSN0709U770, SPSN0709U690, SPSN0605U479, SPSN0605U481, SPSN0901U049, SPSN0901U052, SPSN0704U299, SPSN0605U478, SPSN0901U108, SPSN0901U117, SPSN0810U494, SPSN0901U042, SPSN0904U411, SPSN0605U200, SPSN0605U144, SPSN0908U033, SPSN0605U185, SPSN0605U195, SPSN0703U136, SPSN0703U141, SPSN0703U143, SPSN0703U144, PN1009U435, PN1009U441, PN1010U513, PN1101U051, SPSN0902U209, SPSN0902U214, SPSN0907U024, PN1101U040, PN1101U041, PN1101U045, PN1101U046, PN1102U065, SPSN0705U343, SPSN0705U344, SPSN0705U346, PN1104U246, SPSN0904U445, PN1104U254, SPNS0706U446, SPSN0605U196, P0117198, P0129685, SPSN0605U143, SPSN0605U147, SPSN0906U040, SPSN0907U046, SPSN0907U055, SPSN0906U010, SPSN0907U030, SPSN0909U093, SPSN0906U005, SPSN0906U015, SPSN0904U436, SPSN0904U448, SPSN0901U109, SPSN0605U438, SPSN0605U197, SPSN0605U374, SPSN0904U413, SPSN0904U416, SPSN0705U391, PN1009U438, PN1104U259, PN1104U218, SPSN0905U013, PN1102U111, PN1009U432, SPSN0605U137, SPSN0605U180, SPSN0605U204, SPSN0808U281, SPSN0809U369, SPSN0810U404, SPSN0810U407, SPSN0810U410, SPSN0810U411, SPSN0810U413, SPSN0810U414, SPSN0810U415, SPSN0810U417, SPSN0810U420, SPSN0810U424, SPSN0810U425, SPSN0810U426, SPSN0905U024, SPSNO605U169, SPSNO605U171, SPSN0907U031, SPSN0605U218, SPSN0605U230, PN1102U097, SPSN0901U034, SPSN0901U044, SPSN0710U888, SPSN0710U890, SPSN0801U137 and SPSN0605U402; and Model HEP1001-US,serial numbers P0106584, P0107317, P0107318, P0107319, P0107320, P0107321, P0107322, P0107323, P0107324, P0107325, P0107326, P0107327, P0107328, P0107329, P0107330, P0110043, P0110044, P0110045, P0110046, P0110047, P0110048, P0110049, P0110050, P0110051, P0110052, P0110053, P0110688, P0110689, P0110690, P0110691, P0111667, P0111668, P0111669, P0111670, P0111671, P0111673, P0111812, P0111813, P0111814, P0111815, P0111816, P0111817, P0111818, P0111819, P0112007, P0112036, P0114650, P0114651, P0114652, P0114653, P0114654, P0114655, P0114803, P0114804, P0114805, P0114806, P0114807, P0114808, P0114809, P0114810, P0115724, P0115725, P0115726, P0115727, P0115728, P0115730, P0115731, P0115972, P0115973, P0116052, P0116053, P0116054, P0116055, P0116118, P0116119, P0116120, P0116121, P0116253, P0116254, P0116255, P0116257, P0116258, P0116259, P0116260, P0116261, P0116299, P0120985, P0121186, P0121187, P0121188, P0121190, P0121394, P0121395, P0121396, P0121397, P0123319, P0123320, P0123321, P0123322, P0126545, P0126547, P0126548, P0126745, P0126746, P0126751, P0126752, P0127102, P0127103, P0127104,P0128295, P0128297, P0130472, P0130475, P0136331, PO123323, PS1006U076, PS1006U077, PS1006U078, PS1006U079, PS1006U080, PS1006U081, PS1006U082, PS1006U083, PS1006U084, PS1006U085, PS1006U086, PS1006U087, PS1006U088, PS1006U089, PS1006U090, PS1008U096, PS1008U097, PS1008U098, PS1008U099, PS1008U100, PS1008U101, PS1008U102, PS1008U103, PS1008U104, PS1008U105, PS1008U106, PS1008U107, PS1008U108, PS1008U109, PS1008U110, PS1008U111, PS1008U112, PS1008U113, PS1008U114, PS1008U115, PS1008U116, PS1008U117, PS1008U118, PS1009U120, PS1009U121, PS1009U122. PS1009U125, PS1009U126, PS1009U127, PS1009U128, PS1009U129, PS1009U130, PS1009U131, PS1009U134, PS1009U135, PS1009U136, PS1009U140, PS1009U141, PS1009U142, PS1009U143, PS1009U144, PS1009U145, PS1009U146, PS1009U150, PS1009U151, PS1009U152, PS1009U153, PS1009U154, PS1009U155, PS1009U156, PS1010U162, PS1010U163, PS1010U164, PS1010U165, PS1010U166, PS1010U167, PS1010U168, PS1010U169, PS1010U170, PS1010U171, PS1010U172, PS1010U173, PS1010U174, PS1010U175, PS1010U176, PS1010U177, PS1010U178, PS1010U179, PS1010U180, PS1010U181, PS1010U182, PS1010U183, PS1010U184, PS1012U190, PS1012U191, PS1012U192, PS1012U193, PS1012U195, PS1012U196, PS1012U197, PS1012U198, PS1012U199, PS1012U200, PS1101U002, PS1101U003, PS1101U004, PS1101U005, PS1101U006, PS1101U007, PS1101U009, PS1101U010, PS1102U019, PS1102U020, PS1102U022, PS1102U023, PS1102U024, PS1102U025, PS1102U027, PS1102U028, PS1102U030, PS1102U031, PS1102U032, PS1102U033, PS1102U034, PS1102U035, PS1102U036, PS1102U037, PS1102U039, PS1102U040, PS1102U041, PS1102U042, PS1102U043, PS1102U044, PS1102U045, PS1102U046, PS1102U047, PS1102U048, PS1102U049, PS1102U050, PS1102U052, PS1102U053, PS1102U054, PS1102U057, PS1102U058, PS1102U059, PS1102U061, PS1102U062, PS1102U064, PS1103U065, PS1103U066, PS1103U069, PS1103U070, PS1103U071, PS1103U072, PS1103U073, PS1103U074, PS1103U075, PS1103U076, PS1103U077, PS1103U079, PS1103U081, PS1103U082, PS1103U083, PS1103U084, PS1103U085, PS1103U087, PS1104U112, PS1104U113, PS1104U114, PS1104U115, PS1104U116, PS1104U117, PS1104U118, PS1104U119, PS1104U120, PS1104U121, PS1104U122, PS1104U123, PS1104U125, PS1104U127, PS1104U128, PS1106U132, PS1106U133, PS1106U134, PS1106U137, PS1106U138, PS1106U139, PS1106U140, PS1106U142, PS1106U143, PS1106U144, PS1106U145, PS1106U146, PS1106U148, PS1106U149, PS1106U150, PS1106U151, PS1106U152, PS1106U153, PS1106U154, SPSN0803U355, SPSN0803U356, SPSN0803U357, SPSN0803U358, SPSN0803U359, SPSN0803U360, SPSN0803U361, SPSN0803U362, SPSN0803U363, SPSW0605U100, SPSW0605U101, SPSW0605U102, SPSW0605U103, SPSW0605U104, SPSW0605U105, SPSW0605U106, SPSW0605U107, SPSW0605U108, SPSW0605U109, SPSW0605U110, SPSW0605U111, SPSW0605U112, SPSW0605U113, SPSW0605U114, SPSW0605U115, SPSW0605U116, SPSW0605U117, SPSW0605U118, SPSW0605U119, SPSW0605U120, SPSW0605U121, SPSW0605U122, SPSW0605U123, SPSW0605U124, SPSW0605U125, SPSW0605U126, SPSW0605U127, SPSW0605U128, SPSW0605U129, SPSW0605U130, SPSW0605U131, SPSW0605U132, SPSW0605U133, SPSW0605U157, SPSW0605U158, SPSW0605U159, SPSW0605U160, SPSW0605U161, SPSW0605U162, SPSW0605U163, SPSW0605U251, SPSW0605U252, SPSW0605U253, SPSW0605U254, SPSW0605U255, SPSW0605U256, SPSW0605U257, SPSW0605U258, SPSW0605U259, SPSW0605U260, SPSW0605U261, SPSW0605U262, SPSW0605U263, SPSW0605U264, SPSW0605U265, SPSW0605U266, SPSW0605U267, SPSW0605U268, SPSW0605U269, SPSW0605U270, SPSW0605U271, SPSW0605U272, SPSW0605U273, SPSW0605U274, SPSW0605U275, SPSW0605U276, SPSW0605U277, SPSW0605U278, SPSW0605U279, SPSW0605U280, SPSW0605U281, SPSW0605U282, SPSW0605U283, SPSW0605U284, SPSW0605U285, SPSW0605U286, SPSW0605U288, SPSW0605U289, SPSW0605U290, SPSW0605U291, SPSW0605U293, SPSW0605U294, SPSW0605U295, SPSW0605U296, SPSW0605U297, SPSW0605U298, SPSW0605U299, SPSW0605U300, SPSW0605U301, SPSW0605U302, SPSW0605U303, SPSW0605U304, SPSW0605U305, SPSW0605U306, SPSW0605U307, SPSW0605U308, SPSW0605U309, SPSW0605U310, SPSW0605U311, SPSW0605U312, SPSW0605U313, SPSW0605U314, SPSW0605U315, SPSW0605U316, SPSW0605U317, SPSW0605U318, SPSW0605U319, SPSW0605U320, SPSW0605U321, SPSW0605U322, SPSW0605U323, SPSW0605U324, SPSW0605U325, SPSW0605U326, SPSW0605U327, SPSW0605U328, SPSW0605U329, SPSW0605U330, SPSW0605U331, SPSW0605U332, SPSW0605U333, SPSW0605U334, SPSW0605U335, SPSW0605U336, SPSW0605U337, SPSW0605U338, SPSW0605U339, SPSW0605U340, SPSW0605U341, SPSW0605U342, SPSW0605U343, SPSW0605U344, SPSW0605U345, SPSW0605U346, SPSW0605U347, SPSW0605U348, SPSW0605U349, SPSW0605U485, SPSW0605U486, SPSW0605U487, SPSW0605U488, SPSW0605U489, SPSW0605U490, SPSW0605U491, SPSW0605U492, SPSW0605U493, SPSW0605U494, SPSW0605U495, SPSW0605U496, SPSW0605U497, SPSW0605U498, SPSW0605U499, SPSW0605U500, SPSW0605U501, SPSW0605U502, SPSW0605U503, SPSW0605U504, SPSW0605U505, SPSW0605U506, SPSW0605U507, SPSW0605U508, SPSW0605U509, SPSW0605U510, SPSW0605U511, SPSW0605U512, SPSW0605U513, SPSW0605U514, SPSW0605U515, SPSW0605U516, SPSW0605U517, SPSW0605U518, SPSW0605U519, SPSW0605U520, SPSW0605U521, SPSW0605U522, SPSW0605U523, SPSW0605U524, SPSW0605U525, SPSW0605U526, SPSW0605U527, SPSW0605U528, SPSW0605U529, SPSW0605U530, SPSW0605U531, SPSW0605U532, SPSW0605U533, SPSW0605U534, SPSW0605U535, SPSW0605U536, SPSW0605U537, SPSW0605U538, SPSW0605U539, SPSW0605U540, SPSW0605U541, SPSW0605U542, SPSW0605U543, SPSW0605U544, SPSW0605U545, SPSW0605U546, SPSW0605U547, SPSW0605U548, SPSW0605U549, SPSW0605U550, SPSW0605U551, SPSW0605U552, SPSW0605U553, SPSW0605U554, SPSW0605U555, SPSW0605U556, SPSW0605U557, SPSW0605U558, SPSW0605U559, SPSW0605U560, SPSW0605U561, SPSW0605U562, SPSW0605U564, SPSW0605U565, SPSW0605U566, SPSW0605U567, SPSW0605U568, SPSW0605U569, SPSW0605U570, SPSW0605U571, SPSW0605U572, SPSW0605U573, SPSW0605U574, SPSW0605U575, SPSW0605U576, SPSW0605U577, SPSW0605U578, SPSW0605U579, SPSW0605U580, SPSW0605U581, SPSW0605U582, SPSW0605U583, SPSW0605U584, SPSW0605U585, SPSW0605U586, SPSW0605U587, SPSW0605U588, SPSW0605U589, SPSW0605U590, SPSW0605U591, SPSW0605U592, SPSW0605U593, SPSW0605U594, SPSW0605U595, SPSW0605U596, SPSW0605U597, SPSW0605U598, SPSW0605U599, SPSW0605U600, SPSW0605U601, SPSW0605U602, SPSW0605U603, SPSW0605U604, SPSW0605U605, SPSW0605U607, SPSW0605U608, SPSW0605U609, SPSW0605U611, SPSW0605U612, SPSW0605U613, SPSW0605U614, SPSW0605U615, SPSW0605U616, SPSW0605U617, SPSW0605U618, SPSW0605U619, SPSW0605U620, SPSW0605U621, SPSW0605U622, SPSW0605U623, SPSW0605U624, SPSW0605U625, SPSW0605U626, SPSW0605U627, SPSW0605U628, SPSW0605U629, SPSW0605U631, SPSW0605U632, SPSW0605U633, SPSW0605U634, SPSW0609U778, SPSW0609U779, SPSW0609U780, SPSW0609U781, SPSW0609U782, SPSW0609U783, SPSW0609U784, SPSW0609U785, SPSW0609U786, SPSW0609U787, SPSW0609U788, SPSW0609U789, SPSW0609U790, SPSW0609U791, SPSW0609U792, SPSW0609U793, SPSW0609U794, SPSW0609U795, SPSW0609U796, SPSW0609U797, SPSW0609U798, SPSW0609U799, SPSW0609U800, SPSW0610U828, SPSW0610U829, SPSW0610U830, SPSW0610U831, SPSW0610U832, SPSW0610U833, SPSW0610U834, SPSW0610U835, SPSW0610U836, SPSW0610U837, SPSW0610U838, SPSW0610U839, SPSW0610U841, SPSW0610U842, SPSW0610U843, SPSW0610U844, SPSW0610U845, SPSW0610U846, SPSW0610U847, SPSW0610U848, SPSW0610U849, SPSW0611U866, SPSW0611U867, SPSW0611U868, SPSW0611U869, SPSW0611U870, SPSW0612U928, SPSW0612U929, SPSW0612U930, SPSW0612U931, SPSW0612U932, SPSW0612U933, SPSW0612U934, SPSW0612U935, SPSW0612U936, SPSW0612U937, SPSW0612U938, SPSW0612U939, SPSW0612U940, SPSW0701U984, SPSW0701U985, SPSW0701U986, SPSW0701U987, SPSW0701U988, SPSW0701U989, SPSW0701U990, SPSW0701U991, SPSW0701U992, SPSW0701U993, SPSW0701U994, SPSW0701U995, SPSW0701U996, SPSW0702U056, SPSW0702U057, SPSW0702U058, SPSW0702U059, SPSW0702U060, SPSW0702U061, SPSW0702U062, SPSW0702U063, SPSW0702U064, SPSW0702U065, SPSW0702U066, SPSW0702U067, SPSW0702U068, SPSW0703U204, SPSW0703U205, SPSW0703U206, SPSW0703U207, SPSW0703U208, SPSW0703U209, SPSW0703U210, SPSW0703U211, SPSW0703U212, SPSW0703U213, SPSW0703U214, SPSW0703U215, SPSW0703U216, SPSW0704U244, SPSW0704U245, SPSW0704U246, SPSW0704U247, SPSW0704U248, SPSW0704U249, SPSW0704U250, SPSW0704U251, SPSW0704U252, SPSW0704U253, SPSW0704U254, SPSW0704U255, SPSW0704U256, SPSW0704U257, SPSW0704U258, SPSW0704U259, SPSW0704U260, SPSW0704U261, SPSW0704U262, SPSW0704U263, SPSW0704U264, SPSW0704U265, SPSW0704U266, SPSW0704U302, SPSW0704U303, SPSW0704U304, SPSW0704U305, SPSW0704U306, SPSW0704U307, SPSW0704U308, SPSW0704U309, SPSW0704U310, SPSW0704U311, SPSW0704U312, SPSW0704U313, SPSW0704U314, SPSW0705U351, SPSW0705U352, SPSW0705U353, SPSW0705U354, SPSW0705U355, SPSW0705U356, SPSW0705U357, SPSW0705U358, SPSW0705U359, SPSW0705U360, SPSW0705U361, SPSW0705U362, SPSW0705U363, SPSW0705U400, SPSW0705U401, SPSW0705U402, SPSW0705U403, SPSW0705U404, SPSW0705U405, SPSW0705U406, SPSW0705U407, SPSW0705U408, SPSW0705U409, SPSW0705U410, SPSW0705U411, SPSW0705U412, SPSW0706U450, SPSW0706U451, SPSW0706U452, SPSW0706U453, SPSW0708U497, SPSW0708U498, SPSW0708U499, SPSW0708U500, SPSW0708U501, SPSW0708U502, SPSW0708U503, SPSW0708U504, SPSW0708U505, SPSW0708U506, SPSW0708U550, SPSW0708U551, SPSW0708U552, SPSW0708U553, SPSW0708U554, SPSW0708U555, SPSW0708U556, SPSW0708U558, SPSW0708U559, SPSW0708U561, SPSW0708U562, SPSW0708U598, SPSW0708U599, SPSW0708U624, SPSW0708U625, SPSW0708U626, SPSW0708U627, SPSW0708U628, SPSW0708U629, SPSW0708U630, SPSW0708U631, SPSW0708U632, SPSW0708U633, SPSW0708U634, SPSW0709U673, SPSW0709U674, SPSW0709U675, SPSW0709U676, SPSW0709U677, SPSW0709U678, SPSW0709U679, SPSW0709U680, SPSW0709U681, SPSW0709U682, SPSW0709U683, SPSW0709U684, SPSW0709U685, SPSW0709U713, SPSW0709U714, SPSW0709U715, SPSW0709U716, SPSW0709U717, SPSW0709U718, SPSW0709U719, SPSW0709U720, SPSW0709U721, SPSW0709U722, SPSW0709U723, SPSW0709U724, SPSW0709U725, SPSW0709U726, SPSW0709U727, SPSW0709U728, SPSW0709U729, SPSW0709U748, SPSW0709U749, SPSW0709U750, SPSW0709U751, SPSW0709U752, SPSW0709U755, SPSW0709U756, SPSW0709U757, SPSW0709U758, SPSW0709U759, SPSW0709U760, SPSW0710U793, SPSW0710U794, SPSW0710U795, SPSW0710U796, SPSW0710U797, SPSW0710U798, SPSW0710U799, SPSW0710U800, SPSW0710U801, SPSW0710U802, SPSW0710U803, SPSW0710U804, SPSW0710U805, SPSW0710U806, SPSW0710U807, SPSW0710U808, SPSW0710U809, SPSW0710U810, SPSW0710U811, SPSW0710U812, SPSW0710U813, SPSW0710U814, SPSW0710U815, SPSW0710U816, SPSW0710U817, SPSW0710U818, SPSW0710U819, SPSW0710U820, SPSW0710U821, SPSW0710U822, SPSW0710U823, SPSW0710U824, SPSW0710U825, SPSW0710U826, SPSW0710U827, SPSW0710U851, SPSW0710U852, SPSW0710U853, SPSW0710U854, SPSW0710U855, SPSW0710U857, SPSW0710U858, SPSW0710U859, SPSW0710U860, SPSW0710U861, SPSW0710U862, SPSW0710U863, SPSW0710U864, SPSW0710U865, SPSW0710U868, SPSW0710U869, SPSW0710U870, SPSW0710U871, SPSW0710U873, SPSW0801U075, SPSW0801U076, SPSW0801U077, SPSW0801U078, SPSW0801U079, SPSW0801U080, SPSW0801U081, SPSW0801U082, SPSW0801U083, SPSW0801U084, SPSW0801U085, SPSW0801U141, SPSW0801U142, SPSW0801U143, SPSW0801U144, SPSW0801U145, SPSW0801U146, SPSW0801U147, SPSW0801U148, SPSW0801U149, SPSW0801U150, SPSW0801U151, SPSW0801U152, SPSW0801U153, SPSW0802U231, SPSW0802U233, SPSW0802U235, SPSW0802U236, SPSW0804U394, SPSW0804U395, SPSW0804U410, SPSW0804U411, SPSW0804U412, SPSW0804U413, SPSW0804U414, SPSW0804U415, SPSW0804U416, SPSW0804U417, SPSW0804U418, SPSW0804U419, SPSW0804U420, SPSW0804U421, SPSW0804U422, SPSW0804U423, SPSW0804U424, SPSW0804U425, SPSW0804U426, SPSW0804U427, SPSW0805U023, SPSW0805U024, SPSW0805U025, SPSW0805U026, SPSW0805U027, SPSW0805U028, SPSW0805U029, SPSW0805U031, SPSW0805U032, SPSW0805U033, SPSW0805U034, SPSW0805U035, SPSW0806U080, SPSW0806U081, SPSW0806U082, SPSW0806U083, SPSW0806U084, SPSW0806U085, SPSW0806U086, SPSW0806U087, SPSW0806U088, SPSW0806U089, SPSW0806U090, SPSW0806U091, SPSW0806U092, SPSW0806U093, SPSW0808U167, SPSW0808U168, SPSW0808U169, SPSW0808U170, SPSW0808U171, SPSW0808U172, SPSW0808U173, SPSW0808U174, SPSW0808U175, SPSW0808U176, SPSW0808U177, SPSW0808U178, SPSW0808U209, SPSW0808U210, SPSW0808U211, SPSW0808U212, SPSW0808U213, SPSW0808U214, SPSW0808U215, SPSW0808U216, SPSW0808U217, SPSW0808U218, SPSW0808U287, SPSW0808U289, SPSW0808U290, SPSW0808U291, SPSW0808U292, SPSW0808U293, SPSW0808U294, SPSW0808U295, SPSW0808U296, SPSW0808U297, SPSW0808U298, SPSW0809U305, SPSW0809U306, SPSW0809U307, SPSW0809U308, SPSW0809U309, SPSW0809U310, SPSW0809U311, SPSW0809U312, SPSW0809U313, SPSW0809U314, SPSW0809U328, SPSW0809U329, SPSW0809U330, SPSW0809U331, SPSW0809U332, SPSW0809U333, SPSW0809U334, SPSW0809U335, SPSW0809U336, SPSW0809U337, SPSW0809U338, SPSW0809U339, SPSW0809U340, SPSW0809U341, SPSW0809U342, SPSW0809U380, SPSW0809U381, SPSW0809U382, SPSW0809U383, SPSW0809U384, SPSW0809U385, SPSW0809U386, SPSW0809U387, SPSW0809U388, SPSW0810U427, SPSW0810U428, SPSW0810U429, SPSW0810U430, SPSW0810U431, SPSW0810U432, SPSW0810U433, SPSW0810U434, SPSW0810U435, SPSW0810U436, SPSW0810U437, SPSW0810U438, SPSW0810U439, SPSW0810U440, SPSW0810U441, SPSW0810U442, SPSW0810U443, SPSW0810U444, SPSW0810U445, SPSW0810U446, SPSW0810U447, SPSW0810U448, SPSW0810U449, SPSW0810U453, SPSW0810U454, SPSW0810U455, SPSW0810U456, SPSW0810U457, SPSW0810U458, SPSW0810U459, SPSW0810U460, SPSW0810U461, SPSW0810U462, SPSW0810U463, SPSW0810U464, SPSW0810U465, SPSW0810U466, SPSW0810U467, SPSW0810U468, SPSW0810U469, SPSW0810U470, SPSW0810U472, SPSW0810U473, SPSW0810U474, SPSW0810U513, SPSW0810U514, SPSW0810U516, SPSW0810U563, SPSW0810U564, SPSW0810U565, SPSW0810U566, SPSW0810U567, SPSW0810U568, SPSW0810U569, SPSW0812U624, SPSW0812U625, SPSW0812U626, SPSW0812U627, SPSW0812U629, SPSW0812U630, SPSW0812U631, SPSW0812U633, SPSW0901U053, SPSW0901U055, SPSW0901U056, SPSW0901U057, SPSW0901U061, SPSW0901U062, SPSW0901U063, SPSW0901U064, SPSW0901U065, SPSW0901U066, SPSW0901U067, SPSW0901U068, SPSW0901U070, SPSW0901U072, SPSW0901U073, SPSW0901U074, SPSW0901U119, SPSW0901U120, SPSW0901U121, SPSW0901U122, SPSW0901U123, SPSW0901U124, SPSW0901U125, SPSW0901U126, SPSW0901U127, SPSW0901U128, SPSW0902U219, SPSW0902U220, SPSW0902U221, SPSW0902U222, SPSW0902U223, SPSW0902U224, SPSW0902U225, SPSW0902U226, SPSW0902U227, SPSW0902U228, SPSW0902U229, SPSW0902U230, SPSW0904U352, SPSW0904U353, SPSW0904U354, SPSW0904U355, SPSW0904U356, SPSW0904U357, SPSW0904U358, SPSW0904U359, SPSW0904U360, SPSW0904U361, SPSW0904U362, SPSW0904U363, SPSW0904U365, SPSW0904U367, SPSW0904U368, SPSW0904U369, SPSW0904U370, SPSW0904U371, SPSW0904U372, SPSW0904U373, SPSW0904U374, SPSW0904U455, SPSW0904U456, SPSW0904U457, SPSW0904U458, SPSW0904U459, SPSW0904U460, SPSW0904U461, SPSW0904U462, SPSW0904U464, SPSW0904U465, SPSW0904U466, SPSW0904U467, SPSW0904U468, SPSW0904U469, SPSW0904U470, SPSW0904U471, SPSW0904U472, SPSW0904U473, SPSW0904U474, SPSW0904U475, SPSW0904U476, SPSW0904U477, SPSW0904U478, SPSW0904U479, SPSW0904U480, SPSW0904U481, SPSW0904U483, SPSW0904U484, SPSW0904U485, SPSW0904U486, SPSW0904U487, SPSW0904U488, SPSW0904U489, SPSW0904U490, SPSW0904U491, SPSW0904U492, SPSW0904U493, SPSW0904U494, SPSW0904U496, SPSW0904U497, SPSW0904U498, SPSW0904U499, SPSW0904U500, SPSW0905U028, SPSW0905U029, SPSW0905U030, SPSW0905U031, SPSW0905U032, SPSW0905U033, SPSW0905U034, SPSW0905U035, SPSW0906U017, SPSW0906U018, SPSW0906U020, SPSW0906U023, SPSW0906U024, SPSW0906U025, SPSW0906U026, SPSW0906U045, SPSW0906U047, SPSW0906U048, SPSW0906U049, SPSW0906U050, SPSW0906U051, SPSW0906U052, SPSW0906U053, SPSW0906U054, SPSW0906U055, SPSW0906U056, SPSW0906U057, SPSW0906U058, SPSW0906U064, SPSW0906U065, SPSW0906U066, SPSW0906U067, SPSW0906U068, SPSW0906U069, SPSW0906U070, SPSW0906U071, SPSW0906U072, SPSW0906U073, SPSW0906U074, SPSW0906U075, SPSW0906U076, SPSW0906U077, SPSW0906U078, SPSW0906U079, SPSW0906U080, SPSW0906U081, SPSW0906U082, SPSW0906U083, SPSW0906U084, SPSW0906U085, SPSW0906U086, SPSW0907U066, SPSW0907U067, SPSW0907U068, SPSW0907U069, SPSW0907U070, SPSW0907U071, SPSW0907U072, SPSW0907U073, SPSW0907U074, SPSW0907U075, SPSW0907U076, SPSW0907U077, SPSW0907U078, SPSW0907U079, SPSW0907U080, SPSW0907U081, SPSW0907U082, SPSW0907U083, SPSW0907U085, SPSW0907U086, SPSW0907U087, SPSW0907U088, SPSW0908U036, SPSW0908U037, SPSW0908U038, SPSW0908U039, SPSW0908U040, SPSW0908U041, SPSW0908U042, SPSW0908U043, SPSW0908U044, SPSW0908U045, SPSW0908U046, SPSW0908U047, SPSW0908U048, SPSW0908U049, SPSW0909U097, SPSW0909U098, SPSW0909U099, SPSW0909U100, SPSW0909U101, SPSW0909U102, SPSW0909U104, SPSW0909U106, SPSW0909U107, SPSW0909U109, SPSW0909U110, SPSW0910U143, SPSW0910U144, SPSW0910U145, SPSW0910U146, SPSW0910U147, SPSW0910U148, SPSW0910U149, SPSW0910U150, SPSW0910U151, SPSW0910U152, SPSW0910U153, SPSW0910U154, SPSW0910U155, SPSW0910U156, SPSW0910U157, SPSW0910U158, SPSW0910U159, SPSW0910U160, SPSW0910U161, SPSW0910U162, SPSW0910U163, SPSW0910U164, SPSW0910U165 and STSW0605U331
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Arjo
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ArjoHuntleigh Flowtron ACS900, medical pump recalled | Arjo | Device Malfunction | Nationwide |
| Device | CLASS II | The Concerto Basic Shower Trolley is intended recalled by Arjo | Arjo | Other | 36 states |
| Device | CLASS II | Medium 2-Hooks Spreader Bar for use with Loop Slings recalled by Arjo | Arjo | Other | 5 states |
| Device | CLASS II | Enterprise 9000 Bed recalled by Arjo | Arjo | Device Malfunction | Nationwide |
| Device | CLASS II | Enterprise 8000 Bed recalled by Arjo | Arjo | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |