medical Class II Updated 2025-01-15

Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model 96280, with Service Manual.

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: OK, MN, IA, SC, NE, MI, NY, KY, GA, MO, MT, LA, WA, SD, CO, PA, WY, TX, ID, NJ, FL, OH, MS, OR, AK, IL, AR, KS, AL, TN, WI, VA, NM, CA, IN, RI, NV, MA, NC, ME, CT, AZ, MD

Lot/Code Info: Service Manuals P/N 070-2409-07 and Prior. UDI-DI: 10841522107177, 10841522100246

View official government recall

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