FDA Device recall Z-0809-2025
Xhibit Telemetry Receiver, Model 96280, with Service Manual
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Xhibit Telemetry Receiver, Model 96280, with Service Manual by Spacelabs Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0809-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-25 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spacelabs Healthcare |
| Distribution | 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 |
Product
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Reason
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.
Identifiers
| code_info | Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-11-12 · Spacelabs Healthcare - Brand Name: Branding is not applied to this product
FDA Device · Class II · 2025-10-22 · Spacelabs Healthcare
All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0809-2025%22
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