Lifeline & Reviver View AED (2020-04-20)

Starting date:

April 20, 2020

Posting date:

April 29, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72893

Last updated: 2020-04-29

• 
  Reason
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  Affected products

Affected Products

A. Lifeline View AED

B. Reviver View AED

Reason

As part of the manufacturing process, 4 DDU-2000 units AEDs failed quality tests. Investigation demonstrated that a commercial off-the-shelf (COTS) component with thermal sensitivity within the AED circuitry created a reboot behavior causing error codes to occur during test. This behavior may result in failure to deliver shock and/or failure to deliver shock in range.

Affected products