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Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Recalled January 15, 2025 · FDA recall Z-0810-2025 · Spacelabs Healthcare
Hazard
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. · FDA Class II
Units
434
Sold at
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.
Description
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.
Product
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Manufacturer(s)
Spacelabs Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →