Z-0398-05

Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by...

Name: Z-0398-05 Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by...
Creator: Cardiac Science, Inc.
Published: 2004-11-12
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2004-11-12 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science, Inc. began a recall of Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl... on 2004-11-12. The reason FDA records is "AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to...". 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-0398-05
Status: Terminated
Initiated: 2004-11-12
Posted: 2005-01-15
Terminated: 2006-06-25
Recalling firm: ZOLL Medical Corporation
Product: Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not functionn properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.
Quantity in commerce: 2049
Distribution: Throughout the United States, Canada and Europe.
Product codes and lots: Model no. 9300E serial numbers: 360814 thru 361239, 361320 thru 362359, 362387 thru 362393, 362396 thru 362713, 362916 thru 364194, 364283 thru 364514, and 364606 thru 364914.

Product code MKJ

K031987Class IIIPowerheart AED G3, Model 9300Cardiac Science / cleared 2003-07-30

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)