Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24707
Brand Name:WEBE-5QRVEN
Model:AED Pro Product Family Range
Affected:
Software version:
Recalling Organisation:Zoll Medical New Zealand
1st Floor Unit 1, 29 Acheron Drive
CHRISTCHURCH
Contact Information:03 341 5016
Manufacturer:Zoll Medical Corporation
Issue:Field report of the AED PRO prompting "Unit Failed" during a defibrillation shock attempt. Investigation of this report 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. We have isolated this potential fault to some of the AED PRO units shipped between March 2018 and June 2019. A hardware update is required in order to prevent the defect from occurring.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:17/6/2019
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