HeartStart MRx defribrillator/monitor (2019-05-27)

Starting date:

May 27, 2019

Posting date:

June 7, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70107

Last updated: 2019-06-07

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  Reason
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  Affected products

Affected Products

HeartStart MRx defribrillator/monitor

Reason

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.

Affected products