Z-1938-2019Class II

Powerheart G5 Automatic AED

Name: Z-1938-2019 Powerheart G5 Automatic AED
Creator: Cardiac Science Corporation
Published: 2019-06-04
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2019-06-04 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science Corporation began a recall of Powerheart G5 Automatic AED on 2019-06-04. FDA classified it as Class II and gives the reason as "Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1938-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-04
Posted: 2019-07-03
Terminated: 2021-11-15
Recalling firm: ZOLL Medical Corporation
Product: Powerheart G5 Automatic AED
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 5 devices
Distribution: US distribution to Georgia, Texas, and Wisconsin.
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1938-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1938-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-10	2019-07-03

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)