Health product recall

HeartStart MRx Defibrillator/Monitor (2020-07-24)

Starting date:
July 24, 2020
Posting date:
August 28, 2020
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-73759



Last updated:
2020-08-28

Affected Products

HeartStart MRx Defibrillator/Monitor

Reason

The therapy selector switch, controlled by the therapy knob, is used to turn the HeartStart MRx on in the desired mode of operation and selects the energy setting. The therapy switch may fail, resulting in the device exhibiting the following behaviors:

  • The device may not perform the selected function.
  • The therapy knob may not change to the energy setting selected.
  • The device may deliver a shock with an energy level different from the setting selected by the user.

Affected products

HeartStart MRx Defibrillator/Monitor

Lot or serial number

Not applicable.

Model or catalog number

M3536A

Companies
Manufacturer

Philips Medical Systems

22100 Bothell Everett Highway

Bothell

98021

Washington

UNITED STATES