Device product
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Z-0810-2025
Product summary
- Event
- Event 95910
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 434
- Official record key
device-enforcement:Z-0810-2025
Official wording
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.
Code information: Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
Distribution pattern: US: MN, TX, TN, SC, OK, NM, GA, PA, OH, IA, AL, CO, AR, FL, MO, ME, LA, IL, WA, MA, WI, OR, MS, ID, NY, KS, PR. OUS: Canada, Taiwan, Czech Republic, France, Greece, Italy, Kuwait, Philippines, Poland.
Derived failure modes
-
Device software or design
software versions may