Internal Paddles Option for Defibrillator/Monitor (2020-04-22)

Starting date:

April 22, 2020

Posting date:

May 8, 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-73021

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

Internal Paddles Option for Defibrillator/Monitor

Reason

Internal paddles may wear over time and may not be safe or ready for use, unless the directions in the instructions for use (IFU) to perform routine operational checks are followed. The instructions for use rely on these checks rather than specifying a maximum number of sterilization cycles to determine when the paddles should be discarded.

 

Affected products