Health product recall

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

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

A. Lifeline View AED

Lot or serial number
  • Serial number 400131246
  • Serial number 400131264
Model or catalog number
  • DDU-E2300
Companies
Manufacturer
Defibtech, LLC
741 Boston Post, Suite 201
Guilford
6437
Connecticut
UNITED STATES

B. Reviver View AED

Lot or serial number
  • Serial number 400128145
Model or catalog number
  • DDU-C2300
Companies
Manufacturer
Defibtech, LLC
741 Boston Post, Suite 201
Guilford
6437
Connecticut
UNITED STATES