Z-0623-06

Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are...

Name: Z-0623-06 Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are...
Creator: Cardiac Science Corporation
Published: 2006-01-27
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2006-01-27 / Terminated / root cause: manufacturing process

FDA source

Cardiac Science Corporation began a recall of Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc... on 2006-01-27. The reason FDA records is "Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge". 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-0623-06
Status: Terminated
Initiated: 2006-01-27
Posted: 2006-03-02
Terminated: 2006-06-25
Recalling firm: ZOLL Medical Corporation
Product: Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). 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: Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Affected consignees were notified via telephone. If no phone contact could be made, a Urgent: Medical Device Recall letter dated 02/02/06 was sent with return receipt requested. Customers were asked to locate affected devices and remove them from service. A new AED would be sent to the customers and the customers are asked to return the affected device.
Quantity in commerce: 91
Distribution: 58 customers within the US: AZ, CA, CO, DC,FL, GA, Nationwide, Hungary and Singapore. IL, IN, KS, KY, LA, MI, MO, NC, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI. 2 customers OUS to include: Hungary and Singapore.
Product codes and lots: serial numbers 4000002, 4000004, 4000006, 4000007, 4000009, 4000010, 4000011, 4000013, 4000014, 4000016, 4000018, 4000019, 4000021 thru 4000024, 4000030, 4000031, 4000034, 4000040, 4000044, 4000045, 4000047, 4000048, 4000050, 4000051, 4000054, 4000057, 4000060, 4000063, 4000064, 4000065, 4000067, 4000072, 4000075, 4000079, 4000080, 4000082, 4000085, 4000086, 4000089, 4000090, 4000095, 4000097, 4000098, 4000099, 4000136, 4000138, 4000140, 4000145, 4000156, 4000162, 4000164, 4000179, 4000184, 4000186, 4000187, 4000192, 4000209, 4000215, 4000227, 4000229, 4000230, 4000232, 4000247, 4000249, 4000250, 4000255, 4000256, 4000264, 4000271, 4000274, 4000287, 4000288, 4000291, 4000295, 4000305, 4000306, 4000314, 4000322, 4000323, 4000324, 4000326, 4000330 thru 4000335, 4000337, 4000342.

Product code MKJ

K040438Class IIIPowerheart AED G3aCardiac Science, Inc. / cleared 2004-07-01

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)