CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report
Ultraview SL Command Modules recalled by Spacelabs Healthcare
Spacelabs Healthcare is recalling Ultraview SL Command Modules, distributed nationwide in the US. The recall was initiated on 17 Apr 2015 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-1542-2015
- FDA event ID
- 71074
- Recalling firm
- Spacelabs Healthcare, Snoqualmie, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2015
- FDA classified
- 28 Apr 2015
- Reported
- 6 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Patient Monitors
Timeline
| 17 Apr 2015 | Recall initiated by company | |
| 28 Apr 2015 | Classified by FDA | +11 days |
| 6 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
Where it was distributed
Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.
Nationwide AlabamaDelawareGeorgiaIdahoIllinoisKentuckyLouisianaMassachusettsMaineMichiganMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOregonPennsylvaniaSouth CarolinaTennessee
Questions about this recall
Is Ultraview SL Command Modules recalled?
Yes. Spacelabs Healthcare recalled Ultraview SL Command Modules on 17 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1542-2015.
Why was it recalled?
Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Which lots are affected?
SERIAL NUMBERS IN THE US: 1496-000473, 1496-000590, 1496-001126, 1496-001189, 1496-001214, 1496-001299, 1496-001300, 1496-001301, 1496-001302, 1496-001303, 1496-001304, 1496-001305, 1496-001306, 1496-001307, 1496-001309, 1496-001328, 1496-001329, 1496-001330, 1496-001332, 1496-001333, 1496-001335, 1496-001336, 1496-001337, 1496-001712, 1496-001713, 1496-001714, 1496-002442, 1496-002568, 1496-002691, 1496-002743, 1496-002832, 1496-002833, 1496-002834, 1496-002836, 1496-002837, 1496-002838, 1496-002839, 1496-002840, 1496-002841, 1496-002917, 1496-002918, 1496-002919, 1496-002920, 1496-002998, 1496-002999, 1496-003000, 1496-003001, 1496-003002, 1496-003003, 1496-003005, 1496-003006, 1496-003007, 1496-003021, 1496-003022, 1496-003025, 1496-003035, 1496-003036, 1496-003037, 1496-003042, 1496-003043, 1496-003044, 1496-003046, 1496-003049, 1496-003051, 1496-003055, 1496-003158, 1496-003161, 1496-003162, 1496-003163, 1496-003164, 1496-003179, 1496-003187, 1496-003190, 1496-003191, 1496-003192, 1496-003193, 1496-003210, 1496-003528, 1496-003602, 1496-003796, 1496-003797, 1496-003819, 1496-004075, 1496-004081, 1496-004082, 1496-004088, 1496-004095, 1496-004098, 1496-004100, 1496-004103, 1496-004104, 1496-004110, 1496-004174, 1496-004175, 1496-004222, 1496-004302, 1496-004382, 1496-004385, 1496-004386, 1496-004387, 1496-004390, 1496-004392, 1496-004394, 1496-004622, 1496-004667, 1496-004674, 1496-004675, 1496-004676, 1496-004737, 1496-004762, 1496-004805, 1496-004806, 1496-004886, 1496-004892, 1496-004951, 1496-004980, 1496-005204, 1496-005291, 1496-005292, 1496-005293, 1496-005294, 1496-005342, 1496-005343, 1496-005358, 1496-005359, 1496-005371, 1496-005374, 1496-005380, 1496-005611, 1496-005779, 1496-005780, 1496-005781, 1496-005782, 1496-005785, 1496-005786, 1496-005787, 1496-005889, 1496-005890, 1496-005891, 1496-005892, 1496-005894, 1496-005896, 1496-005897, 1496-005898, 1496-005899, 1496-005900, 1496-005901, 1496-005903, 1496-005904, 1496-005905, 1496-006038, 1496-006058, 1496-006078, 1496-006089, 1496-006108, 1496-006109, 1496-006110, 1496-006140, 1496-006141, 1496-006142, 1496-006143, 1496-006144, 1496-006145, 1496-006249, 1496-006250, 1496-006251, 1496-006252, 1496-006253, 1496-006254, 1496-006255, 1496-006256, 1496-006257, 1496-006258, 1496-006259, 1496-006260, 1496-006261, 1496-006262, 1496-006266, 1496-006267, 1496-006268, 1496-006269, 1496-006270, 1496-006271, 1496-006272, 1496-006273, 1496-006327, 1496-006328, 1496-006329, 1496-006330, 1496-006331, 1496-006332, 1496-006333, 1496-006334, 1496-006336, 1496-006337, 1496-006338, 1496-006341, 1496-006342, 1496-006343, 1496-006457, 1496-006472, 1496-006523, 1496-006544, 1496-006593, 1496-006594, 1496-006595, 1496-006596, 1496-006597, 1496-006877, 1496-006972, 1496-006973, 1496-006981, 1496-006982, 1496-006983, 1496-006984, 1496-006985, 1496-006986, 1496-006994, 1496-006995, 1496-006996, 1496-006997, 1496-006998, 1496-007132, 1496-007137, 1496-007318, 1496-007319, 1496-007320, 1496-007321, 1496-007322, 1496-007323, 1496-007324, 1496-007325, 1496-007326, 1496-007327, 1496-007328, 1496-007329, 1496-007330, 1496-007331, 1496-007332, 1496-007333, 1496-007334, 1496-007335, 1496-007336, 1496-007337, 1496-007338, 1496-007339, 1496-007340, 1496-007376, 1496-007587, 1496-007589, 1496-007590, 1496-007593, 1496-007594, 1496-007595, 1496-007596, 1496-007631, 1496-007647, 1496-007650, 1496-007651, 1496-007652, 1496-007653, 1496-007654, 1496-007655, 1496-007656, 1496-007657, 1496-007658, 1496-007745, 1496-007750, 1496-007753, 1496-007755, 1496-007756, 1496-007757, 1496-007969, 1496-007970, 1496-008009, 1496-008010, 1496-008011, 1496-008012, 1496-008013, 1496-008014, 1496-008015, 1496-008046, 1496-008047, 1496-008048, 1496-008161, 1496-008162, 1496-008163, 1496-008250, 1496-008319, 1496-008383, 1496-008450, 1496-008451, 1496-008452, 1496-008453, 1496-008454, 1496-008455, 1496-008456, 1496-008580, 1496-008584, 1496-008587, 1496-008873, 1496-009392, 1496-009393, 1496-009394, 1496-009395, 1496-009396, 1496-009397, 1496-009398, 1496-009399, 1496-009400, 1496-009401, 1496-009524, 1496-009584, 1496-009585, 1496-009586, 1496-009587, 1496-009588, 1496-009589, 1496-009590, 1496-009591, 1496-009592, 1496-009593, 1496-009594, 1496-009595, 1496-009596, 1496-009597, 1496-009598, 1496-009599, 1496-009600, 1496-009601, 1496-009602, 1496-009603, 1496-009604, 1496-009605, 1496-009606, 1496-009607, 1496-009608, 1496-009715, 1496-009733, 1496-009734, 1496-009737, 1496-009738, 1496-009760, 1496-009761, 1496-009762, 1496-009763, 1496-009764, 1496-009765, 1496-009766, 1496-009767, 1496-009778, 1496-009779, 1496-009781, 1496-009782, 1496-009783, 1496-009784, 1496-009785, 1496-009786, 1496-009787, 1496-009788, 1496-009856, 1496-009861, 1496-009862, 1496-009867, 1496-009874, 1496-009877, 1496-009879, 1496-009963, 1496-009968, 1496-010008, 1496-010009, 1496-010010, 1496-010011, 1496-010012, 1496-010013, 1496-010017, 1496-010018, 1496-010019, 1496-010068, 1496-010113, 1496-010252, 1496-010260, 1496-010273, 1496-010278, 1496-010287, 1496-010288, 1496-010290, 1496-010291, 1496-010292, 1496-010293, 1496-010294, 1496-010295, 1496-010296, 1496-010297, 1496-010298, 1496-010299, 1496-010300, 1496-010301, 1496-010302, 1496-010469, 1496-010470, 1496-010471, 1496-010472, 1496-010473, 1496-010474, 1496-010475, 1496-010476, 1496-010477, 1496-010478, 1496-010523, 1496-010524, 1496-010526, 1496-010527, 1496-010528, 1496-010529, 1496-010530, 1496-010531, 1496-010532, 1496-010533, 1496-010534, 1496-010535, 1496-010537, 1496-010539, 1496-010540, 1496-010541, 1496-010542, 1496-010543, 1496-010545, 1496-010546, 1496-010547, 1496-010548, 1496-010550, 1496-010691, 1496-010692, 1496-010809, 1496-010830, 1496-010927, 1496-010933, 1496-010952, 1496-010959, 1496-010960, 1496-011059, 1496-011060, 1496-011069, 1496-011070, 1496-011210, 1496-011211, 1496-011246, 1496-011247, 1496-011248, 1496-011249, 1496-011250, 1496-011252, 1496-011253, 1496-011256, 1496-011259, 1496-011306, 1496-011307, 1496-011308, 1496-011309, 1496-011310, 1496-011311, 1496-011312, 1496-011313, 1496-011314, 1496-011315, 1496-011317, 1496-011552, 1496-011555, 1496-011716, 1496-011894, 1496-011902, 1496-011908, 1496-011923, 1496-012278, 1496-012280, 1496-012307, 1496-012320, 1496-012343, 1496-012426, 1496-012429, 1496-012431, 1496-012432, 1496-012434, 1496-012470, 1496-012478, 1496-012495, 1496-012496, 1496-012497, 1496-012615, 1496-012616, 1496-012617, 1496-012618, 1496-012620, 1496-012621, 1496-012623, 1496-012624, 1496-012625, 1496-012626, 1496-012628, 1496-012629, 1496-012630, 1496-012631, 1496-012632, 1496-012633, 1496-012634, 1496-012635, 1496-012636, 1496-012637, 1496-012638, 1496-012639, 1496-012640, 1496-012642, 1496-013314, 1496-013383, 1496-013563, 1496-013564, 1496-013565, 1496-013566, 1496-013567, 1496-013568, 1496-013569, 1496-013570, 1496-013571, 1496-013572, 1496-013573, 1496-013574, 1496-013575, 1496-013578, 1496-013579, 1496-013580, 1496-013583, 1496-013584, 1496-013585, 1496-013586, 1496-013587, 1496-013588, 1496-013590, 1496-013591, 1496-013683, 1496-013705, 1496-013706, 1496-013709, 1496-013710, 1496-013711, 1496-013712, 1496-013713, 1496-013732, 1496-013733, 1496-013734, 1496-013735, 1496-013998, 1496-013999, 1496-014000, 1496-014001, 1496-014002, 1496-014003, 1496-014004, 1496-014005, 1496-014006, 1496-014007, 1496-014008, 1496-014009, 1496-014010, 1496-014011, 1496-014012, 1496-014015, 1496-014016, 1496-014017, 1496-014018, 1496-014019, 1496-014020, 1496-014065, 1496-014135, 1496-014136, 1496-014172, 1496-014173, 1496-014174, 1496-014175, 1496-014177, 1496-014178, 1496-014179, 1496-014180, 1496-014181, 1496-014339, 1496-014340, 1496-014341, 1496-014342, 1496-014343, 1496-014344, 1496-014345, 1496-014346, 1496-014348, 1496-014349, 1496-014350, 1496-014351, 1496-014352, 1496-014353, 1496-014354, 1496-014355, 1496-014356, 1496-014357, 1496-014358, 1496-014359, 1496-014360, 1496-014361, 1496-014362, 1496-014445, 1496-014446, 1496-014447, 1496-014448, 1496-014449, 1496-014451, 1496-014462, 1496-014484, 1496-014485, 1496-014486, 1496-014487, 1496-014506, 1496-014517, 1496-014536, 1496-014537, 1496-014542, 1496-014552, 1496-014554, 1496-014555, 1496-014835, 1496-014964, 1496-014965, 1496-014966, 1496-014967, 1496-014968, 1496-014970, 1496-014971, 1496-014972, 1496-014973, 1496-014974, 1496-014975, 1496-014976, 1496-014978, 1496-014979, 1496-014980, 1496-014982, 1496-014983, 1496-014984, 1496-014985, 1496-014986, 1496-014988, 1496-015059, 1496-015082, 1496-015084, 1496-015181, 1496-015183, 1496-015184, 1496-015185, 1496-015217, 1496-015218, 1496-015219, 1496-015220, 1496-015221, 1496-015222, 1496-015223, 1496-015224, 1496-015225, 1496-015226, 1496-015227, 1496-015228, 1496-015229, 1496-015230, 1496-015231, 1496-015232, 1496-015233, 1496-015234, 1496-015235, 1496-015236, 1496-015237, 1496-015257, 1496-015258, 1496-015259, 1496-015260, 1496-015261, 1496-015263, 1496-015264, 1496-015265, 1496-015266, 1496-015267, 1496-015268, 1496-015269, 1496-015270, 1496-015272, 1496-015273, 1496-015274, 1496-015276, 1496-015277, 1496-015278, 1496-015279, 1496-015280, 1496-015281, 1496-015282, 1496-015283, 1496-015284, 1496-015285, 1496-015286, 1496-015288, 1496-015289, 1496-015290, 1496-015292, 1496-015293, 1496-015294, 1496-015295, 1496-015296, 1496-015297, 1496-015298, 1496-015299, 1496-015300, 1496-015301, 1496-015302, 1496-015303, 1496-015304, 1496-015312, 1496-016051, 1496-016052, 1496-016053, 1496-016056, 1496-016249, 1496-016250, 1496-016499, 1496-016509, 1496-016526, 1496-016527, 1496-016530, 1496-016804, 1496-016870, 1496-016938, 1496-016946, 1496-016956, 1496-016959, 1496-016960, 1496-016965, 1496-016966, 1496-016967, 1496-016968, 1496-016969, 1496-016970, 1496-016972, 1496-016974, 1496-016975, 1496-016977, 1496-016979, 1496-016980, 1496-016981, 1496-016983, 1496-016984, 1496-016985, 1496-016986, 1496-016987, 1496-017379, 1496-017408, 1496-017409, 1496-017410, 1496-017411, 1496-017412, 1496-017413, 1496-017414, 1496-017415, 1496-017416, 1496-017417, 1496-017418, 1496-017419, 1496-017420, 1496-017421, 1496-017422, 1496-017423, 1496-017424, 1496-017425, 1496-017426, 1496-017427, 1496-017428, 1496-017429, 1496-017430, 1496-017431, 1496-017432, 1496-017433, 1496-017434, 1496-017435, 1496-017436, 1496-017437, 1496-017438, 1496-017439, 1496-017440, 1496-017441, 1496-017442, 1496-017443, 1496-017444, 1496-017445, 1496-017446, 1496-017447, 1496-017448, 1496-017449, 1496-017491, 1496-017492, 1496-017493, 1496-017494, 1496-017547, 1496-017548, 1496-017549, 1496-017550, 1496-017551, 1496-017552, 1496-017555, 1496-017556, 1496-017557, 1496-017558, 1496-017559, 1496-017560, 1496-017561, 1496-017562, 1496-017563, 1496-017564, 1496-017599, 1496-017659, 1496-017660, 1496-017661, 1496-017663, 1496-017664, 1496-017665, 1496-017666, 1496-017667, 1496-017882, 1496-017883, 1496-017884, 1496-017885, 1496-017886, 1496-017888, 1496-017889, 1496-017890, 1496-017891, 1496-017892, 1496-017893, 1496-017895, 1496-017896, 1496-017897, 1496-017898, 1496-017899, 1496-017900, 1496-017901, 1496-017902, 1496-017903, 1496-017904, 1496-017905, 1496-018140, 1496-018277, 1496-018498, 1496-018499, 1496-018501, 1496-018506, 1496-018511, 1496-018512, 1496-018513, 1496-018657, 1496-018658, 1496-018659, 1496-018660, 1496-018661, 1496-018662, 1496-018663, 1496-018664, 1496-018665, 1496-018666, 1496-018667, 1496-018668, 1496-018669, 1496-018670, 1496-018671, 1496-018672, 1496-018673, 1496-018674, 1496-018675, 1496-018676, 1496-018715, 1496-018716, 1496-018717, 1496-018719, 1496-018720, 1496-018721, 1496-018722, 1496-019217, 1496-019221, 1496-019491, 1496-019492, 1496-019584, 1496-020047, 1496-020049, 1496-020073, 1496-020074, 1496-020075, 1496-020076, 1496-020077, 1496-020078, 1496-020079, 1496-020080, 1496-020081, 1496-020082, 1496-020083, 1496-020084, 1496-020085, 1496-020086, 1496-020087, 1496-020088, 1496-020089, 1496-020090, 1496-020091, 1496-020178, 1496-020278, 1496-020279, 1496-020280, 1496-020281, 1496-020282, 1496-020283, 1496-020284, 1496-020293, 1496-020294, 1496-020295, 1496-020296, 1496-020297, 1496-020298, 1496-020308, 1496-020311, 1496-020348, 1496-020349, 1496-020350, 1496-020807, 1496-021310, 1496-021443, 1496-021457, 1496-021458, 1496-021459, 1496-021460, 1496-021461, 1496-021462, 1496-021463, 1496-021464, 1496-021465, 1496-021466, 1496-021467, 1496-021468, 1496-021469, 1496-021470, 1496-021471, 1496-021472, 1496-021473, 1496-021474, 1496-021475, 1496-021476, 1496-021477, 1496-021478, 1496-021479, 1496-021480, 1496-021481, 1496-021482, 1496-021483, 1496-021484, 1496-021485, 1496-021486, 1496-021487, 1496-021488, 1496-021504, 1496-021505, 1496-021506, 1496-021507, 1496-021508, 1496-021509, 1496-021510, 1496-021511, 1496-021512, 1496-021513, 1496-021520, 1496-021677, 1496-021715, 1496-021723, 1496-021743, 1496-021758, 1496-023510, 1496-023558, 1496-023559, 1496-023560, 1496-023561, 1496-023563, 1496-023564, 1496-023565, 1496-023566, 1496-023567, 1496-023858, 1496-024742, 1496-024804, 1496-024832, 1496-025119, 1496-025120, 1496-025121, 1496-025122, 1496-025123, 1496-025124, 1496-025126, 1496-025197, 1496-025199, 1496-025202, 1496-025203, 1496-025204, 1496-025205, 1496-025206, 1496-025207, 1496-025208, 1496-025209, 1496-025234, 1496-025235, 1496-025236, 1496-025237, 1496-025238, 1496-025506, 1496-025512, 1496-025513, 1496-025514, 1496-025515, 1496-025516, 1496-025517, 1496-025518, 1496-025618, 1496-025619, 1496-025654, 1496-025657, 1496-025658, 1496-025660, 1496-025661, 1496-025662, 1496-025663, 1496-025664, 1496-025665, 1496-025666, 1496-025667, 1496-025668, 1496-025669, 1496-025670, 1496-025671, 1496-025672, 1496-025673, 1496-025674, 1496-025675, 1496-025676, 1496-025677, 1496-025678, 1496-025679, 1496-025680, 1496-025681, 1496-025682, 1496-025683, 1496-025684, 1496-025685, 1496-025686, 1496-025687, 1496-025688, 1496-025689, 1496-025690, 1496-025691, 1496-025692, 1496-025693, 1496-025694, 1496-025695, 1496-025696, 1496-025697, 1496-025698, 1496-025699, 1496-025701, 1496-025702, 1496-025704, 1496-025705, 1496-025706, 1496-025707, 1496-025708, 1496-025709, 1496-025710, 1496-025769, 1496-025770, 1496-025771, 1496-025941, 1496-025942, 1496-026067, 1496-026068, 1496-026070, 1496-026072, 1496-026075, 1496-026076, 1496-026077, 1496-026078, 1496-026079, 1496-026080, 1496-026081, 1496-026082, 1496-026083, 1496-026309, 1496-026310, 1496-026311, 1496-026362, 1496-026363, 1496-026364, 1496-026365, 1496-026366, 1496-026367, 1496-026368, 1496-026369, 1496-026370, 1496-026373, 1496-026374, 1496-026429, 1496-027022, 1496-027070, 1496-027071, 1496-027103, 1496-027111, 1496-027112, 1496-027409, 1496-027410, 1496-027411, 1496-027412, 1496-027413, 1496-027414, 1496-027415, 1496-027416, 1496-027472, 1496-027578, 1496-027579, 1496-027580, 1496-027581, 1496-028419, 1496-028442, 1496-028459, 1496-028461, 1496-028462, 1496-028465, 1496-028466, 1496-028467, 1496-028665, 1496-028710, 1496-028711, 1496-028822, 1496-028824, 1496-028825, 1496-028826, 1496-028827, 1496-028829, 1496-028831, 1496-028832, 1496-028833, 1496-028834, 1496-028836, 1496-028837, 1496-028838, 1496-028839, 1496-028840, 1496-028841, 1496-028842, 1496-028843, 1496-028844, 1496-028845, 1496-028846, 1496-028847, 1496-028848, 1496-028850, 1496-028851, 1496-028852, 1496-028853, 1496-028854, 1496-028855, 1496-029028, 1496-029051, 1496-029575, 1496-029595, 1496-029723, 1496-029724, 1496-029725, 1496-029726, 1496-029727, 1496-029728, 1496-029985, 1496-030010, 1496-030932, 1496-030933, 1496-030934, 1496-031144, 1496-031145, 1496-031190, 1496-031784, 1496-031785, 1496-031786, 1496-031787, 1496-031788, 1496-031789, 1496-031790, 1496-031791, 1496-031792, 1496-031793, 1496-031794, 1496-031795, 1496-031796, 1496-031798, 1496-031799, 1496-031800, 1496-031802, 1496-031803, 1496-031804, 1496-031805, 1496-031806, 1496-031807, 1496-031809, 1496-031810, 1496-031811, 1496-031812, 1496-031814, 1496-031815, 1496-031816, 1496-032015, 1496-032016, 1496-032375, 1496-032414, 1496-032418, 1496-032660, 1496-032661, 1496-032662, 1496-032663, 1496-032721, 1496-032792, 1496-032793, 1496-033426, 1496-033785, 1496-034033, 1496-034251, 1496-034259, 1496-034260, 1496-034261, 1496-034262, 1496-034263, 1496-034264, 1496-034265, 1496-034266, 1496-034267, 1496-034268, 1496-034540, 1496-034553, 1496-034560, 1496-034583, 1496-034711, 1496-034712, 1496-034713, 1496-034925, 1496-035276, 1496-035296, 1496-035417, 1496-036293, 1496-036294, 1496-036295, 1496-036424, 1496-037006, 1496-037007, 1496-037008, 1496-037009, 1496-037010, 1496-037011, 1496-037012, 1496-037013, 1496-037014, 1496-037015, 1496-037157, 1496-037158, 1496-037633, 1496-037684, 1496-037685, 1496-037686, 1496-037687, 1496-037688, 1496-037689, 1496-045292, 1496-045293, 1496-045294, 1496-045295, 1496-045296, 1496-045297, 1496-045310, 1496-045626, 1496-045627, 1496-045628, 1496-045909, 1496-045911, 1496-045913, 1496-045914, 1496-045915, 1496-045916, 1496-046010, 1496-046011, 1496-046012, 1496-046013, 1496-046761, 1496-046763, 1496-046764, 1496-046765, 1496-046766, 1496-046767, 1496-046768, 1496-046769, 1496-046770, 1496-046771, 1496-046772, 1496-046773, 1496-046774, 1496-046775, 1496-046776, 1496-046777, 1496-046779, 1496-046780, 1496-048077, 1496-048078, 1496-048079, 1496-048081, 1496-048082, 1496-048083, 1496-048175, 1496-048176, 1496-049930, 1496-100886, 1496-100887, 1496-100888, 1496-100889, 1496-100890, 1496-100891, 1496-100892, 1496-100893, 1496-100894, 1496-100895, 1496-100896, 1496-100897, 1496-100898, 1496-100899, 1496-101134, 1496-101140, 1496-101141, 1496-101148, 1496-101151, 1496-101189, 1496-101190, 1496-101191, 1496-101192, 1496-101193, 1496-101194, 1496-101195, 1496-101196, 1496-101197, 1496-101198, 1496-101199, 1496-101200, 1496-101202, 1496-101203, 1496-101204, 1496-101205, 1496-102018, 1496-102019, 1496-102020, 1496-102021, 1496-102022, 1496-102023, 1496-102024, 1496-102025, 1496-102026, 1496-102027, 1496-102045, 1496-102054, 1496-102055, 1496-102056, 1496-102057, 1496-102058, 1496-102158, 1496-102159, 1496-102160, 1496-102161, 1496-102163, 1496-102164, 1496-102165, 1496-102216, 1496-102549, 1496-102655, 1496-102656, 1496-102657, 1496-102658, 1496-102659, 1496-102787, 1496-102788, 1496-102789, 1496-102790, 1496-102791, 1496-103435, 1496-103436, 1496-103437, 1496-103438, 1496-103439, 1496-103440, 1496-103441, 1496-103610, 1496-103611, 1496-103639, 1496-103710, 1496-103711, 1496-103712, 1496-103713, 1496-103714, 1496-103715, 1496-103716, 1496-103717, 1496-103718, 1496-103719, 1496-104419, 1496-104424, 1496-104425, 1496-104426, 1496-104427, 1496-104428, 1496-104547, 1496-104548, 1496-104549, 1496-104550, 1496-104551, 1496-104552, 1496-104553, 1496-104554, 1496-104555, 1496-104556, 1496-104557, 1496-104558, 1496-104559, 1496-104560, 1496-104561, 1496-104563, 1496-104564, 1496-104565, 1496-104566, 1496-104567, 1496-104568, 1496-105356, 1496-105357, 1496-105358, 1496-105360, 1496-105373, 1496-105382, 1496-105383, 1496-105688, 1496-105747, 1496-105748, 1496-105749, 1496-105750, 1496-105751, 1496-105752, 1496-105753, 1496-105754, 1496-105755, 1496-105756, 1496-105757, 1496-105758, 1496-105759, 1496-105760, 1496-105761, 1496-105762, 1496-105763, 1496-105764, 1496-105766, 1496-105767, 1496-105768, 1496-105769, 1496-105770, 1496-105771, 1496-105772, 1496-105773, 1496-105774, 1496-105775, 1496-105776, 1496-105777, 1496-105778, 1496-105779, 1496-105780, 1496-105781, 1496-105782, 1496-105783, 1496-105784, 1496-105785, 1496-105786, 1496-105787, 1496-105788, 1496-105789, 1496-105790, 1496-105791, 1496-105792, 1496-105793, 1496-105794, 1496-105795, 1496-105796, 1496-105797, 1496-105798, 1496-105799, 1496-105800, 1496-105801, 1496-105802, 1496-105803, 1496-105804, 1496-105805, 1496-105806, 1496-105807, 1496-105808, 1496-105809, 1496-105810, 1496-105811, 1496-105812, 1496-105813, 1496-105814, 1496-105815, 1496-105816, 1496-105817, 1496-105818, 1496-105819, 1496-105821, 1496-105822, 1496-105823, 1496-105824, 1496-105825, 1496-105826, 1496-105827, 1496-105828, 1496-105829, 1496-105830, 1496-105831, 1496-105832, 1496-105833, 1496-105834, 1496-105835, 1496-105836, 1496-105837, 1496-105838, 1496-105839, 1496-105840, 1496-105841, 1496-105842, 1496-105843, 1496-105844, 1496-105845, 1496-105846, 1496-105847, 1496-105848, 1496-105849, 1496-105850, 1496-105851, 1496-105852, 1496-105853, 1496-105854, 1496-105855, 1496-105856, 1496-105857, 1496-105858, 1496-105859, 1496-105860, 1496-105861, 1496-105862, 1496-105863, 1496-105864, 1496-105865, 1496-105866, 1496-105867, 1496-105868, 1496-105869, 1496-105870, 1496-105871, 1496-105872, 1496-105873, 1496-105874, 1496-105875, 1496-105876, 1496-105877, 1496-105878, 1496-105879, 1496-105880, 1496-105881, 1496-105882, 1496-105883, 1496-105884, 1496-105885, 1496-105886, 1496-105887, 1496-105888, 1496-105889, 1496-105890, 1496-105891, 1496-105892, 1496-105893, 1496-105894, 1496-105895, 1496-105896, 1496-105897, 1496-105898, 1496-105899, 1496-105900, 1496-105901, 1496-105902, 1496-105903, 1496-105904, 1496-105905, 1496-105906, 1496-105907, 1496-105908, 1496-105909, 1496-105910, 1496-105911, 1496-105912, 1496-105913, 1496-105914, 1496-105915, 1496-105916, 1496-105917, 1496-105918, 1496-105919, 1496-105920, 1496-105921, 1496-105922, 1496-105923, 1496-105924, 1496-105925, 1496-105926, 1496-105927, 1496-105928, 1496-105929, 1496-105930, 1496-105931, 1496-105932, 1496-105933, 1496-105934, 1496-105935, 1496-105936, 1496-105937, 1496-105938, 1496-105939, 1496-105940, 1496-105941, 1496-105942, 1496-105943, 1496-105944, 1496-105945, 1496-105946, 1496-105947, 1496-105948, 1496-105949, 1496-105950, 1496-105951, 1496-105952, 1496-105953, 1496-105954, 1496-105955, 1496-105956, 1496-105957, 1496-105958, 1496-105959, 1496-105960, 1496-105961, 1496-105962, 1496-105963, 1496-105964, 1496-105965, 1496-105966, 1496-105967, 1496-105968, 1496-105969, 1496-105970, 1496-105971, 1496-105972, 1496-105973, 1496-105974, 1496-105975, 1496-105976, 1496-105977, 1496-105978, 1496-105979, 1496-105980, 1496-105981, 1496-105982, 1496-105983, 1496-105984, 1496-105985, 1496-105986, 1496-105987, 1496-105988, 1496-105989, 1496-105990, 1496-105991, 1496-105992, 1496-105993, 1496-105994, 1496-105995, 1496-105996, 1496-105997, 1496-105998, 1496-105999, 1496-106000, 1496-106001, 1496-106002, 1496-106003, 1496-106004, 1496-106005, 1496-106006, 1496-106007, 1496-106008, 1496-106009, 1496-106010, 1496-106011, 1496-106012, 1496-106013, 1496-106014, 1496-106015, 1496-106016, 1496-106017, 1496-106018, 1496-106019, 1496-106020, 1496-106021, 1496-106022, 1496-106023, 1496-106024, 1496-106025, 1496-106026, 1496-106027, 1496-106028, 1496-106029, 1496-106030, 1496-106031, 1496-106032, 1496-106033, 1496-106034, 1496-106035, 1496-106036, 1496-106037, 1496-106038, 1496-106039, 1496-106040, 1496-106041, 1496-106042, 1496-106043, 1496-106044, 1496-106045, 1496-106046, 1496-106047, 1496-106048, 1496-106049, 1496-106050, 1496-106051, 1496-106052, 1496-106053, 1496-106054, 1496-106055, 1496-106056, 1496-106057, 1496-106058, 1496-106059, 1496-106060, 1496-106061, 1496-106062, 1496-106063, 1496-106064, 1496-106065, 1496-106066, 1496-106067, 1496-106068, 1496-106069, 1496-106070, 1496-106071, 1496-106072, 1496-106073, 1496-106074, 1496-106286, 1496-106287, 1496-106288, 1496-106289, 1496-106290, 1496-106291, 1496-106292, 1496-106293, 1496-106294, 1496-106295, 1496-106296, 1496-106297, 1496-106298, 1496-106299, 1496-106300, 1496-106301, 1496-106302, 1496-106303, 1496-106304, 1496-106305, 1496-106306, 1496-106307, 1496-106308, 1496-106309, 1496-106310, 1496-106311, 1496-106458, 1496-106459, 1496-106460, 1496-106461, 1496-106462, 1496-106463, 1496-106464, 1496-106465, 1496-106466, 1496-106467, 1496-106468, 1496-106469, 1496-106470, 1496-106471, 1496-106472, 1496-106498, 1496-106500, 1496-106501, 1496-106502, 1496-106503, 1496-106504, 1496-106505, 1496-106506, 1496-106507, 1496-106508, 1496-106509, 1496-106510, 1496-106511, 1496-106512, 1496-106513, 1496-106514, 1496-106515, 1496-106516, 1496-106517, 1496-106518, 1496-106519, 1496-106520, 1496-106521, 1496-106522, 1496-106523, 1496-106524, 1496-106525, 1496-106526, 1496-106527, 1496-106528, 1496-106529, 1496-107878, 1496-107882, 1496-107884, 1496-107903, 1496-107904, 1496-107905, 1496-107906, 1496-109257, 1496-109258, 1496-109259, 1496-109260, 1496-109261, 1496-109263, 1496-109264, 1496-109265, 1496-109266, 1496-109267, 1496-109298, 1496-109299, 1496-109300, 1496-109301, 1496-109302, 1496-109303, 1496-109304, 1496-109305, 1496-109306, 1496-109322, 1496-109323, 1496-109324, 1496-109325, 1496-112374, 1496-112632, 1496-117845, 1496-120087, 1496-120088, 1496-120089, 1496-120090, 1496-120091, 1496-120605, 1496-120725, 1496-120726, 1496-120727, 1496-120728, 1496-120729, 1496-120730, 1496-120731, 1496-120732, 1496-120733, 1496-120734, 1496-120757, 1496-120758, 1496-120759, 1496-120760, 1496-120761, 1496-120762, 1496-120763, 1496-120764, 1496-120765, 1496-120766, 1496-120767, 1496-120768, 1496-120769, 1496-121121, 1496-121973, 1496-121974, 1496-121975, 1496-121976, 1496-121977, 1496-121978, 1496-121979, 1496-121980, 1496-121981, 1496-121982, 1496-121983, 1496-121984, 1496-121985, 1496-121986, 1496-121987, 1496-121988, 1496-121989, 1496-121990, 1496-121991, and 1496-121992. **********SERIAL NUMBERS INTERNATIONAL********************************* 1496-001139, 1496-001925, 1496-002364, 1496-002372, 1496-002410, 1496-002411, 1496-002483, 1496-002486, 1496-002501, 1496-002509, 1496-002521, 1496-002542, 1496-002543, 1496-003059, 1496-006322, 1496-006323, 1496-006324, 1496-006702, 1496-009407, 1496-009518, 1496-009550, 1496-009739, 1496-009953, 1496-009979, 1496-010250, 1496-010251, 1496-010257, 1496-010259, 1496-010261, 1496-010779, 1496-011011, 1496-011322, 1496-011553, 1496-011927, 1496-012393, 1496-012715, 1496-012729, 1496-014969, 1496-016724, 1496-017329, 1496-019070, 1496-033510, 1496-038108, 1496-113895, 1496-113896, 1496-113911, 1496-113935, 1496-113936, 1496-113938, 1496-113939, 1496-113940, 1496-113941, 1496-113944, 1496-113945, 1496-113946, 1496-113947, 1496-113948, 1496-113949, 1496-113950, 1496-113951, 1496-113952, 1496-113953, 1496-113954, 1496-113956, 1496-113957, 1496-113958, and 1496-113959.
Where was it sold?
Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.
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 Spacelabs Healthcare
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xhibit Central Station recalled by Spacelabs Healthcare | Spacelabs Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Spacelabs Ultraview SL Command Module SL Command Module recalled | Spacelabs Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Multi-parameter Command Module recalled by Spacelabs Healthcare | Spacelabs Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Sentinel V11 recalled by Spacelabs Healthcare | Spacelabs Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Branding is not applied to this product DVI display cables recalled | Spacelabs Healthcare | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |