Home / Recalls / Medical Devices
Spacelabs Healthcare, Inc. recalls Xhibit Telemetry Receiver, Model: 96280
Recalled August 17, 2022 · FDA recall Z-1513-2022 · Spacelabs Healthcare
Hazard
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure. · FDA Class II
Units
529
Sold at
Worldwide distribution - US Nationwide distribution in the states of NY, AR, CO, FL, NJ, AL, KY, TN, SC, WA, OK, MN, PA, GA, VA, CA, OH, IA, KS, MI, IN, TX, MT, MO, ME, LA, IL, SD, MA, OR, ID, MD, AZ, AK and the countries of MB, ON, FR, QC, BC, IS, CT, RM.
Description
Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does not occur in the telemetry receiver as specified. Caregiver may not respond to the initial technical alarm and may not be aware of the continuing technical failure.
Product
Xhibit Telemetry Receiver, Model: 96280
Manufacturer(s)
Spacelabs Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →