Health product recall

HeartStart MRX Defibrillator/Monitor (2020-02-26)

Starting date:
February 26, 2020
Posting date:
April 15, 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-72723

Last updated: 2020-04-15

Affected Products 

HeartStart MRX Defibrillator/Monitor

Reason

Philips has received a number of reports of HeartStart MRX Defibrillator/Monitor that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the ready for use ("rfu") indicator on the unit did not immediately indicate a problem.

Affected products

HeartStart MRX Defibrillator/Monitor

Lot or serial number

Not applicable.

Model or catalog number
  • M3535A
  • M3536A
Companies
Manufacturer
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
Washington
UNITED STATES