FDA Device recall Z-0810-2025
Xhibit Telemetry Receiver with Software, Model 96280
- FDA Device
- Class II
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class II recall of Xhibit Telemetry Receiver with Software, Model 96280 by Spacelabs Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2025 |
| 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 | 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 |
Product
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Reason
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.
Identifiers
| code_info | Software Versions: 1.4.0 and 1.4.1. 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-0810-2025%22
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