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Health product recall

Heartstart MRx Defibrillator/Monitor (2014-11-17)

Starting date:
November 17, 2014
Posting date:
December 4, 2014
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-42779

Recalled Products

Heartstart MRx Defibrillator/Monitor

Reason

Philips has become aware that the Heartstart MRx Defibrillator/Monitor can be susceptible to one or both of the issues described below.

  1. The CO2 inlet port associated with end-tidal Carbon Dioxide (etCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. This can occur if the user attempts to push the CO2 filter line fitting into the inlet port, instead of twisting it clockwise as described in the MRx instructions for use.
  2. he handle can separate from the MRx housing due to breakage of mounts on the rear case.

Affected products

Heartstart MRx Defibrillator/Monitor

Lot or serial number

M3535A:US00100100 - US00552845

M3536A:US00100902 - US00552848

Model or catalog number

M3535A

M3536A

Companies
Manufacturer

Philips Medical Systems

3000 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES