HeartStart MRx Defibrillator/Monitor, HeartStart MRx Defibrillator/Monitor with Q-CPR, QCPR - CPR Meter, and QCPR - CPR Meter Upgrade Kit (2018-01-25)
- Starting date:
- January 25, 2018
- Posting date:
- February 9, 2018
- 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-65934
Affected products
- HEARTSTART MRX DEFIBRILLATOR/MONITOR- Q-CPR
- HEARTSTART MRX DEFIBRILLATOR/MONITOR
- QCPR - CPR METER
- QCPR - CPR METER UPGRADE KIT
Reason
Philips is sending this letter as a formal notice of a Medical Device Labeling Correction
- To ensure HeartStart MRx customers have access to the HeartStart MRx Addendum as a supplement to the MRx Instructions for Use (IFU)
- To ensure HeartStart FR3 customers whose Q-CPR Meters are used on an MRx are aware that certain information contained in the FR3 AED Instructions for Administrators (IFA) and the FR3 Q-CPR Meter Instructions for Use (IFU) also applies to use of the Q-CPR Meters with the MRx.
Affected products
A. HEARTSTART MRX DEFIBRILLATOR/MONITOR- Q-CPR
Lot or serial number
All lots.
Model or catalog number
M4761A
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
B. HEARTSTART MRX DEFIBRILLATOR/MONITOR
Lot or serial number
All lots.
Model or catalog number
M3535A
M3536A
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
C. QCPR - CPR METER
Lot or serial number
All lots.
Model or catalog number
453564145481
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
D. QCPR - CPR METER UPGRADE KIT
Lot or serial number
All lots.
Model or catalog number
861444
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES