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Lifepak 15 Monitor/Defibrillator
- Starting date:
- December 23, 2016
- Posting date:
- January 25, 2017
- 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-61960
Reason
The LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (relay) installed on the therapy printed circuit board assembly (PCBA). A malfunction of the relay can be identified during the user test of the device, as described in the chapter titled "Maintaining the Equipment" within the LIFEPAK 15 operating instructions.
Affected products
Lifepak 15 Monitor/Defibrillator
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 99577-XXXXXX
Companies
- Manufacturer
-
Physio-Control Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES