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Heartstart XL (2014-02-21)
- Starting date:
- February 21, 2014
- Posting date:
- March 21, 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-38533
Recalled Products
Heartstart XL
Reason
Philips has become aware that an internal component on the Heartstart XL Defibrillator/Monitor power board may malfunction potentially affecting the ability to deliver therapy. Specifically, the Heartstart XL Defibrillator/Monitor may be unable to charge and deliver a shock. In addition, when used for external pacing, the malfunction may result in a loss of capture.
Affected products
Heartstart XL
Lot or serial number
M4735A
Model or catalog number
All lots
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES