Product Wiki · Recalls · Health Canada — Medical Devices

ITS4850A Intellivue Telemetry System (2020-02-28) — recall 63240

Health Canada — Medical Devices · Canada · 2020-03-13 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
63240
Date of alert
2020-03-13
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The ECG signal from patients being monitored using a Philips TRx4851A Telemetry Transceiver may not be properly analyzed when the transceiver is used with a Philips Patient Information Center iX Release C.02.00, C.02.02, C.02.03 (all released versions of C.02, collectively referred to as ‘C.02.xx') or C.03.01. If this occurs, the Information Center will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms. Alarming based on pulse oximetry (SpO2) signals are unaffected by this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/its4850a-intellivue-telemetry-

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