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: 2019-06-17

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  Reason
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  Affected products

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