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

• Reason
• Affected products

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