FDA-Device2022-08-17Class II
Xhibit Telemetry Receiver, Model: 96280
Spacelabs Healthcare, Inc.
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.
Sold states
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.
Affected count
529
Manufactured in
35301 Se Center St, Snoqualmie, WA, United States
Products
Xhibit Telemetry Receiver, Model: 96280
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2022Don't want to check this manually?
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