Z-1000-03

Zoll M Series External Defibrillator

Name: Z-1000-03 Zoll M Series External Defibrillator
Creator: Zoll Medical Corporation
Published: 2003-06-23
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2003-06-23 / Terminated

FDA source

Zoll Medical Corporation began a recall of Zoll M Series External Defibrillator on 2003-06-23. The reason FDA records is "Defibrillator may fail to charge or hold its charge above energies of 75 joules". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1000-03
Status: Terminated
Initiated: 2003-06-23
Posted: 2003-07-10
Terminated: 2020-12-29
Recalling firm: ZOLL Medical Corporation
Product: Zoll M Series External Defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Defibrillator may fail to charge or hold its charge above energies of 75 joules
FDA root cause: Other
Action: Zoll Medical issued a letter on 6/25/03 to domestic consignees and 6/26/03 to international consignees on 6/26/03. Letters were issued Certified Mail Return Receipt requested. Instructions are provided for Biomedical to charge device and then dump the charge. A damaged device will fail to charge and issue an error message. Users then are requested to return device. Firm will initiate telephone contact on 6/30/03 to all accounts to verify receipt of notice and confirmation of testing per the instructions.
Quantity in commerce: 8,142 units
Distribution: Nationwide Foreign: Emirates, Australia, Brussels, Brazil, Canada, China, Columbia, Chezche, Germany, Spain, Finland, France, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea, Kuwait, Latvia, Mexico, Netherlands, Poland,Romania, Saudi Arabia, Syrai, Thailand, Turkey,
Product codes and lots: Serial Numbers: T02I37097-T03C45238

Product code MKJ

K972241Class IIIZoll ReviverZoll Medical Corp / cleared 1998-03-16

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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)