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Terminated

Powerheart G5 Automatic AED

FDA Recall Z-1938-2019 · Posted None

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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