Xhibit Telemetry Receiver, Model: 96280
FDA Device Recall #Z-1513-2022 — Class II — May 31, 2022
Recall Summary
| Recall Number | Z-1513-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 31, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Spacelabs Healthcare, Inc. |
| Location | Snoqualmie, WA |
| Product Type | Devices |
| Quantity | 529 |
Product Description
Xhibit Telemetry Receiver, Model: 96280
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.
Distribution Pattern
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.
Lot / Code Information
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
Other Recalls from Spacelabs Healthcare, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0169-2026 | Class II | Brand Name: Branding is not applied to this pro... | Sep 5, 2025 |
| Z-0168-2026 | Class II | Brand Name: Branding is not applied to this pro... | Sep 5, 2025 |
| Z-0167-2026 | Class II | Brand Name: Branding is not applied to this pro... | Sep 5, 2025 |
| Z-0809-2025 | Class II | Xhibit Telemetry Receiver, Model 96280, with Se... | Nov 25, 2024 |
| Z-0810-2025 | Class II | Xhibit Telemetry Receiver with Software, Model ... | Nov 25, 2024 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.