Powerheart G5 Automatic AED recallZ-1938-2019 · Cardiac Science Corporation · initiated Jun 4, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardiac Science Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-1938-2019
- Status
- Terminated
- Initiated by the company
- Jun 4, 2019
- Recalling firm
- Cardiac Science Corporation
- Quantity
- 5 devices
- Product code
- MKJ
- FDA submissions
- P160033
- Distribution
- US distribution to Georgia, Texas, and Wisconsin.
Product description
Powerheart G5 Automatic AED
Code information (models, lots, serial numbers)
Model Number G5A 80A; AED Serial Number (UDI Number): D00000133922 )(01)00812394021222(11)190508(21)D00000133922), D00000133927 ((01)00812394021222(11)190509(21)D00000133927), D00000133930 ((01)00812394021222(11)190509(21)D00000133930), D00000133934 ((01)00812394021222(11)190509(21)D00000133934), D00000133936 )(01)00812394021222(11)190509(21)D00000133936).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Powerheart G5 Auto G5A-80P1Zoll Medical Corporation · Automated External Defibrillators (Non-Wearable)1 recall6 deaths494 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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