ZOLL AED Pro External Defibillator (2019-06-11)

Starting date:
June 11, 2019
Posting date:
June 18, 2019
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-70221

Last updated:

Affected Products

ZOLL AED Pro External Defibillator

Reason

A field report was received of the AED Pro prompting "unit failed" during a defibrillation shock attempt. Investigation traced the problem to an area of an internal circuit board that is susceptible to isolation breakdown. If the isolation breakdown occurs during a shock attempt, the device will issue the "unit failed" message and prevent delivery of the energy to the patient.

Affected products

ZOLL AED Pro External Defibillator

Lot or serial number

Not applicable.

Model or catalog number

ZOLL AED PRO

Companies
Manufacturer
Zoll Medical Corporation
269 Mill Road
Chelmsford
01824
Massachusetts
UNITED STATES