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Health product recall

Heartstart MRX Defibrillator / Monitor and QCPR-CPR Meter Upgrade Kit (2014-02-26)

Starting date:
February 26, 2014
Posting date:
March 25, 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-38597

Recalled Products

A. Heartstart MRX Defibrillator / Monitor

B. QCPR-CPR Meter Upgrade Kit

Reason

Philips has become aware of the following issues regarding the Heartstart MRX monitor/defibrillator:

when the Heartstart MRX is in AED mode, the Q-CPR meter is designed to display the 'Do not touch the patient' icon during the shock advisory analysis period. If the user continues to deliver chest compressions when the shock advisory analysis begins, the 'Do not touch the patient' icon may incorrectly remain on the screen after analysis or shock delivery is complete.  

When the Heartstart MRX is in manual mode, the Q-CPR meter is designed to display the 'Do not touch the patient' icon when the device is charging to the selected energy. If the clinician continues to provide chest compressions while the device is charging, the Q-CPR meter 'Do not touch the patient" icon may incorrectly remain on the screen after shock delivery is complete.

Affected products

A. Heartstart MRX Defibrillator / Monitor

Lot or serial number

M3535A

M3536A

Model or catalog number

All lots

Companies
Manufacturer

Philips Medical Systems

3000 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


B. QCPR-CPR Meter Upgrade Kit

Lot or serial number

861444

Model or catalog number

All lots

Companies
Manufacturer

Philips Medical Systems

3000 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES