Product Wiki · Recalls · Health Canada — Medical Devices

INTERNAL PADDLES OPTION FOR DEFIBRILLATOR/MONITOR (2020-09-17) — recall 61734

Health Canada — Medical Devices · Canada · 2020-10-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61734
Date of alert
2020-10-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/internal-paddles-option-defibr

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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