HeartStart MRx defribrillator/monitor (2019-05-27)
- Starting date:
- May 27, 2019
- Posting date:
- June 7, 2019
- 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-70107
Last updated: 2019-06-07
Affected Products
HeartStart MRx defribrillator/monitor
Reason
If the HeartStart MRx is used without a charged M3538A lithium ion battery installed, the device may not operate if AC mains power is interrupted or if the AC Power Module does not function properly. If the M3539A ac power module fails, or AC mains power to the HeartStart MRx is otherwise interrupted, without a charged M3538A lithium ion battery installed, as directed in the device's instructions for use, the HeartStart MRx may lose all power and fail to operate. A faulty AC Power Module may also fail to charge the battery.
Affected products
HeartStart MRx defribrillator/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