medical Class II Updated 2025-01-15

Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software, Model 96280. Inten

Recalled Product

Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.


Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: Software Versions: 1.4.0 and 1.4.1. UDI-DI: 10841522107177, 10841522100246
View official government recall

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