INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR (2020-09-17)
- Starting date:
- September 17, 2020
- Posting date:
- October 9, 2020
- 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-74081
Last updated:
2020-10-09
Affected Products
INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR
Reason
Philips determined that the insulation between conductors in the affected switched internal paddles may break down over multiple use cycles. This is a failure mode that may not be detected by the existing tests identified in the paddle checks section of the Instructions for Use (IFU). Early signs of insulation breakdown can be detected by adding an insulation resistance test to the existing paddle checks for the switched internal paddles only.
Affected products
INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR
Lot or serial number
All lots.
Model or catalog number
M1741A
M1742A
M1743A
M1744A
M4741A
M4742A
M4743A
M4744A
Companies
- Manufacturer
-
Philips Medical Systems
22100 Bothell Everett Highway
Bothell
98021
Washington
UNITED STATES