Powerheart G5 Automatic AED
FDA Recall Z-1938-2019 · Posted None
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Recalling FirmCardiac Science Corporation
Recall StatusTerminated
Product CodeMKJ
Date Initiated2019-06-04
Date Terminated2021-11-15
Product Quantity5 devices
Reason for Recall
Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
Firm Action
Cardiac Science Corporation notified customers of the recall on about 06/04/2019 via phone call and "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Customers were instructed to examine inventory, remove any affected devices, and contact Cardiac Science immediately to arrange for return of affected devices and replacement of new devices. Contact can be made by phone to 800.426.0337 option 1 or by email at [email protected].
Distributors were instructed to determine who received the affected devices, inform customers that a Cardiac Science representative will contact them and provided a list with customer names, contact information (including phone and email addresses) and affected device serial numbers to Cardiac Science. The list can be provided by calling 800.426.0337 or by emailing it to [email protected].
Root Cause
Process control
Distribution Pattern
US distribution to Georgia, Texas, and Wisconsin.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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