FDA-Device2025-01-15Class II
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Spacelabs Healthcare, Inc.
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.
Sold states
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.
Affected count
434
Manufactured in
35301 Se Center St, Snoqualmie, WA, United States
Products
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2025Don't want to check this manually?
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