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Health product recall

Heartstart Mrx Defibrillator/Monitor (2017-02-27)

Starting date:
February 27, 2017
Posting date:
March 16, 2017
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-62658

Affected Products

A. Heartstart Mrx Defibrillator/Monitor
B. Heartstart Mrx Defibrillator/Monitor

Reason

Philips has become aware of the following issues:

1. If the pins that connect the battery to the device have become damaged or full of debris, the device may not power on or may repetitively reboot.

2. When the device is unplugged from AC mains, it may enter a state where it will not charge for shock delivery or may unexpectedly cease pacing.

Affected products

A. Heartstart Mrx Defibrillator/Monitor

Lot or serial number

All lots

Model or catalog number

M3536A

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES

B. Heartstart Mrx Defibrillator/Monitor

Lot or serial number

All lots

Model or catalog number

M3535A

Companies
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES