Z-0548-03

Zoll AED Plus Defibrillator (Automatic External Defibrillator)

Name: Z-0548-03 Zoll AED Plus Defibrillator (Automatic External Defibrillator)
Creator: Zoll Medical Corporation
Published: 2002-12-17
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2002-12-17 / Terminated

FDA source

Zoll Medical Corporation began a recall of Zoll AED Plus Defibrillator (Automatic External Defibrillator) on 2002-12-17. The reason FDA records is "Defibrillator may fail to function due to false detection of safety fault condition". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0548-03
Status: Terminated
Initiated: 2002-12-17
Posted: 2003-02-06
Terminated: 2004-04-21
Recalling firm: ZOLL Medical Corporation
Product: Zoll AED Plus Defibrillator (Automatic External Defibrillator)
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Defibrillator may fail to function due to false detection of safety fault condition
FDA root cause: Other
Action: Zoll Medical notified Direct accounts by letter issued Overnight Certified Mail on 12/17/02 to Domestic Accounts and 12/18/02 to International accounts.
Quantity in commerce: 5,597 units
Distribution: Nationwide to : Hospitals, EMT, Police and Fire Rescue
Product codes and lots: Serial Numbers: X02F000812 through X02K007486

Product code MKJ

K011388Class IIIZoll PadZoll Medical Corp / cleared 2002-03-25

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)