11
Aug
2022

Recall- Software Error Leads to Technical Alarm Escalation

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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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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