FDA Device recall Z-1513-2022
Xhibit Telemetry Receiver, Model: 96280
- FDA Device
- Class II
- ongoing
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of Xhibit Telemetry Receiver, Model: 96280 by Spacelabs Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1513-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-31 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
Product
Xhibit Telemetry Receiver, Model: 96280
Reason
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.
Identifiers
| code_info | UDI-DI: 10841522100246, Software version 1.4.0. Serial Numbers: 6280-001538, 6280-000590, 6280-000589, 6280-000339, 928…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1513-2022%22
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