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

• Reason
• Affected products

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