Company: Spacelabs Healthcare, Inc.
Date of Enforcement Report: 8/11/2022
CLASS: II
PRODUCT
Xhibit Telemetry Receiver, Model: 96280
Recall Number:
Z-1513-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Inc.Voluntary. Firm Initiated
VOLUME OF PRODUCT IN COMMERCE
529
DISTRIBUTION
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.
