This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
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.
- 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.
- 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