Xhibit Telemetry Receiver, Model: 96280
Reported: August 17, 2022 Initiated: May 31, 2022 #Z-1513-2022
Product Description
Xhibit Telemetry Receiver, Model: 96280
Reason for Recall
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.
Details
- Recalling Firm
- Spacelabs Healthcare, Inc.
- Units Affected
- 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.
- Location
- Snoqualmie, WA
Frequently Asked Questions
What product was recalled? ▼
Xhibit Telemetry Receiver, Model: 96280. Recalled by Spacelabs Healthcare, Inc.. Units affected: 529.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2022. Severity: Moderate. Recall number: Z-1513-2022.
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