CLASS II ONGOING Device recall · Reported 17 Aug 2022 · FDA Enforcement Report
Xhibit Telemetry Receiver recalled by Spacelabs Healthcare
Spacelabs Healthcare is recalling Xhibit Telemetry Receiver, distributed nationwide in the US. The recall was initiated on 31 May 2022 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-1513-2022
- FDA event ID
- 90529
- Recalling firm
- Spacelabs Healthcare, Snoqualmie, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 May 2022
- FDA classified
- 11 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 31 May 2022 | Recall initiated by company | |
| 11 Aug 2022 | Classified by FDA | +72 days |
| 17 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Xhibit Telemetry Receiver, Model: 96280
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it recalled?
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
Which lots are affected?
UDI-DI: 10841522100246, Software version 1.4.0. Serial Numbers: 6280-001538, 6280-000590, 6280-000589, 6280-000339, 9280-000711, 6280-001103, 6280-001102, 6280-001469, 6280-001467, 6280-001686, 6280-001399, 6280-001323, 6280-000457, 6280-000456, 6280-000455, 6280-000440, 6280-000439, 6280-000438, 6280-000429, 6280-000476, 6280-000475, 6280-001693, 6280-000703, 6280-000702, 6280-000701, 6280-000700, 6280-000314, 6280-000258, 6280-000157, 6280-001223, 6280-001222, 6280-001221, 6280-001220, 6280-001219, 6280-001218, 6280-001217, 6280-001216, 6280-001215, 6280-001214, 6280-001207, 6280-001127, 6280-001125, 6280-001124, 6280-001123, 6280-001056, 6280-001055, 6280-001054, 6280-001053, 6280-001052, 6280-001051, 6280-001050, 6280-001288, 6280-001287, 6280-001490, 6280-001692, 6280-000588, 6280-000517, 6280-000516, 6280-000515, 6280-001668, 6280-000206, 6280-000162, 6280-000210, 6280-000663, 6280-000377, 6280-001589, 6280-001385, 6280-001384, 6280-001382, 6280-001405, 6280-000594, 6280-000593, 6280-000592, 6280-000596, 6280-000274, 6280-001844, 6280-001843, 6280-001721, 6280-001720, 6280-000136, 6280-001784, 6280-001783, 6280-000359, 6280-000340, 6280-000336, 6280-001718, 6280-001706, 6280-001705, 6280-001704, 6280-001703, 6280-001702, 6280-001699, 6280-001698, 6280-001672, 6280-001669, 6280-000622, 6280-001797, 6280-000097, 6280-001558, 6280-001551, 6280-001649, 6280-001648, 6280-001647, 6280-001646, 6280-001645, 6280-001594, 6280-000093, 6280-001168, 6280-001531, 6280-001670, 6280-000219, 6280-000550, 6280-000878, 6280-000877, 6280-000872, 6280-000862, 6280-000858, 6280-000857, 6280-000221, 6280-000089, 6280-000204, 6280-000212, 6280-000510, 6280-000509, 6280-000209, 6280-000320, 6280-000538, 6280-000528, 6280-000205, 6280-000361, 6280-000360, 6280-000223, 6280-000963, 6280-000529, 6280-001575, 6280-001574, 6280-001573, 6280-001572, 6280-001571, 6280-001570, 6280-000467, 6280-000466, 6280-000465, 6280-000464, 6280-000463, 6280-000462, 6280-000461, 6280-000460, 6280-000459, 6280-000458, 6280-000222, 6280-000264, 6280-000275, 6280-000354, 6280-001677, 6280-001048, 6280-001043, 6280-001041, 6280-001038, 6280-001037, 6280-001036, 6280-001023, 6280-001022, 6280-001016, 6280-000787, 6280-001418, 6280-001419, 6280-001416, 6280-000894, 6280-000866, 6280-000865, 6280-000863, 6280-000902, 6280-000898, 6280-000724, 6280-000420, 6280-000419, 6280-000798, 6280-000325, 6280-000532, 6280-000521, 6280-000213, 6280-000254, 6280-000856, 6280-000855, 6280-000854, 6280-000853, 6280-000852, 6280-000851, 6280-001143, 6280-001142, 6280-001141, 6280-000472, 6280-000375, 6280-000368, 6280-000421, 6280-000519, 6280-001213, 6280-000836, 6280-000835, 6280-000834, 6280-000833, 6280-000832, 6280-000831, 6280-000586, 6280-001473, 6280-000319, 6280-000263, 6280-000312, 6280-000579, 6280-000092, 6280-000090, 6280-000084, 6280-000083, 6280-000079, 6280-001380, 6280-001466, 6280-001458, 6280-001611, 6280-001592, 6280-001591, 6280-000388, 6280-000161, 6280-000160, 6280-000159, 6280-000158, 6280-000066, 6280-000053, 6280-000174, 6280-000173, 6280-000172, 6280-000170, 6280-000168, 6280-000167, 6280-000077, 6280-000598, 6280-000355, 6280-000344, 6280-000341, 6280-000338, 6280-000468, 6280-000423, 6280-000478, 6280-000477, 6280-000454, 6280-000428, 6280-000261, 6280-001614, 6280-001642, 6280-001641, 6280-001640, 6280-001639, 6280-001638, 6280-001637, 6280-001636, 6280-001635, 6280-001634, 6280-001633, 6280-001632, 6280-001631, 6280-001630, 6280-001629, 6280-001913, 6280-000138, 6280-000437, 6280-000436, 6280-000177, 6280-000176, 6280-000337, 6280-001857, 6280-001853, 6280-001749, 6280-001359, 6280-001160, 6280-001159, 6280-001158, 6280-001157, 6280-001156, 6280-001154, 6280-001132, 6280-001112, 6280-001109, 6280-000991, 6280-000983, 6280-001189, 6280-001188, 6280-001205, 6280-001204, 6280-001203, 6280-001202, 6280-001200, 6280-001194, 6280-001193, 6280-001184, 6280-001166, 6280-000358, 6280-000357, 6280-000345, 6280-000432, 6280-000431, 6280-000811, 6280-000693, 6280-000690, 6280-000929, 6280-001063, 6280-001062, 6280-001061, 6280-001060, 6280-000391, 6280-001273, 6280-001554, 6280-001553, 6280-001261, 6280-000426, 6280-001525, 6280-000229, 6280-000876, 6280-000875, 6280-000745, 6280-000208, 6280-000574, 6280-000218, 6280-001087, 6280-000045, 6280-000041, 6280-000374, 6280-000373, 6280-001257, 6280-001256, 6280-001255, 6280-001254, 6280-001253, 6280-001252, 6280-001251, 6280-001250, 6280-001249, 6280-000840, 6280-000486, 6280-001825, 6280-000543, 6280-000542, 6280-000839, 6280-000879, 6280-001325, 6280-001071, 6280-001070, 6280-001069, 6280-000900, 6280-000897, 6280-001822, 6280-001874, 6280-001872, 6280-001871, 6280-000695, 6280-000540, 6280-000541, 6280-000539, 6280-000166, 6280-000624, 6280-000614, 6280-000613, 6280-000612, 6280-000611, 6280-000610, 6280-000609, 6280-000608, 6280-000607, 6280-000630, 6280-000629, 6280-000628, 6280-000627, 6280-000626, 6280-001644, 6280-001619, 6280-001617, 6280-000587, 6280-000490, 6280-000489, 6280-000488, 6280-000487, 6280-000974, 6280-000973, 6280-000972, 6280-000971, 6280-000970, 6280-000969, 6280-000968, 6280-000967, 6280-000966, 6280-000965, 6280-000329, 6280-000326, 6280-000318, 6280-001621, 6280-001609, 6280-001596, 6280-001536, 6280-001381, 6280-001340, 6280-001339, 6280-001338, 6280-001337, 6280-001336, 6280-001335, 6280-001334, 6280-001315, 6280-001312, 6280-001311, 6280-000547, 6280-000546, 6280-000545, 6280-000544, 6280-000518, 6280-001764, 6280-001752, 6280-001751, 6280-001746, 6280-001548, 6280-001408, 6280-001431, 6280-001729, 6280-001046, 6280-000601, 6280-001350, 6280-000689, 6280-001487, 6280-001475, 6280-000928, 6280-000927, 6280-000926, 6280-000925, 6280-000901, 6280-001329, 6280-001331, 6280-001330, 6280-001342, 6280-001341, 6280-000514, 6280-000513, 6280-000512, 6280-000511, 6280-000530, 6280-000108, 6280-000107, 6280-000106, 6280-000105, 6280-000104, 6280-000103, 6280-000102, 6280-000101, 6280-000100, 6280-000600, 6280-000276, 6280-001374, 6280-000195, 6280-000192, 6280-000189, 6280-000187, 6280-000178, 6280-000194, 6280-001820, 6280-001805, 6280-001444, 6280-001225, 6280-000850, 6280-000725, 6280-000694, 6280-000553, 6280-000549, 6280-000548, 6280-000330, 6280-000317, 6280-000188, 6280-000182, 6280-000290, 6280-001818, 6280-001765, 6280-001602, 6280-001601, 6280-001450, 6280-001449, 6280-001377, 6280-001376, 6280-001178, 6280-001049, 6280-000796, 6280-000743, 6280-000491, 6280-000356, 6280-000295, 6280-000293, 6280-000292, 6280-000291, 6280-000231, 6280-000196, 6280-000061, 6280-000060, 6280-000473, 6280-000232, 6280-000062, 6280-001319, 6280-001313, 6280-000384, 6280-000199, 6280-000198, 6280-000065, 6280-000064, 6280-000237, 6280-000406, 6280-000401, 6280-000362, 6280-000270, 6280-000400, 6280-001245, 6280-001101, 6280-000873, 6280-000871, 6280-000870, 6280-000861, 6280-000860, 6280-000815, 6280-000554, 6280-000527, 6280-000499, 6280-000416, 6280-000371, 6280-000197, 6280-000523, 6280-000063
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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