Product Wiki · Recalls · Health Canada — Medical Devices

HeartStart MRx defribrillator/monitor (2019-05-27) — recall 44564

Health Canada — Medical Devices · Canada · 2019-06-07 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44564
Date of alert
2019-06-07
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: If the HeartStart MRx is used without a charged M3538A lithium ion battery installed, the device may not operate if AC mains power is interrupted or if the AC Power Module does not function properly. If the M3539A ac power module fails, or AC mains power to the HeartStart MRx is otherwise interrupted, without a charged M3538A lithium ion battery installed, as directed in the device's instructions for use, the HeartStart MRx may lose all power and fail to operate. A faulty AC Power Module may also fail to charge the battery.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartstart-mrx-defribrillatorm

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