Xhibit Telemetry Receiver with Software — Class II medical device recall Z-0810-2025
Ongoing recall by Spacelabs Healthcare, Inc., reported 2025-01-15, distributed in AL, AR, CO, FL, GA, IA, ID, IL…. Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (O
| Recall number | Z-0810-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Inc., Snoqualmie, WA, United States |
| Recall initiated | 2024-11-25 |
| Classified | 2025-01-07 |
| Reported by FDA | 2025-01-15 |
| Distributed | AL, AR, CO, FL, GA, IA, ID, IL, KS, LA, MA, ME, MN, MO, MS, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, WA, WI |
| Countries outside the US | CA, CZ, FR, GR, IT, KW, PH, PL, TW |
| Quantity | 434 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10841522100246, 10841522107177 |
| Model numbers | 96280 |
Product
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Reason for recall
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.
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-0810-2025. 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.