Xhibit Telemetry Receiver — Class II medical device recall Z-0809-2025
Ongoing recall by Spacelabs Healthcare, Inc., reported 2025-01-15, distributed in AK, AL, AR, AZ, CA, CO, CT, FL…. Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (O
| Recall number | Z-0809-2025 |
|---|---|
| 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 | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY |
| Countries outside the US | AU, CA, CH, CZ, ES, FR, GB, GR, HK, IT, KW, MX, MY, NL, PA, PH, PL, SA, TW |
| Quantity | 2,265 |
| UPC / GTIN / UDI-DI | 10841522100246, 10841522107177 |
| Model numbers | 96280 |
Product
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Reason for recall
Telemetry receiver systems may experience a Windows proxy Issue causing the system to 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; 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-0809-2025. 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.