Xhibit Telemetry Receiver — Class II medical device recall Z-1513-2022
Ongoing recall by Spacelabs Healthcare, Inc., reported 2022-08-17, distributed nationwide. Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm
| Recall number | Z-1513-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Inc., Snoqualmie, WA, United States |
| Recall initiated | 2022-05-31 |
| Classified | 2022-08-11 |
| Reported by FDA | 2022-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 529 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10841522100246 |
| Serial numbers | 6280-000041, 6280-000045, 6280-000053, 6280-000060, 6280-000061, 6280-000062, 6280-000063, 6280-000064, 6280-000065, 6280-000066, 6280-000077, 6280-000079, 6280-000083, 6280-000084, 6280-000089, 6280-000090, 6280-000092, 6280-000093, 6280-000097, 6280-000100, 6280-000101, 6280-000102, 6280-000103, 6280-000104, 6280-000105 and 475 more |
| Model numbers | 96280 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1513-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.