Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1513-2022 — Xhibit Telemetry Receiver, Model: 96280

U.S. FDA — Device Enforcement · United States · 2022-05-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1513-2022
Date of alert
2022-05-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spacelabs Healthcare, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10841522100246
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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