Z-1206-2009

Zoll AED Plus Defibrillator

Name: Z-1206-2009 Zoll AED Plus Defibrillator
Creator: ZOLL Medical Corporation, World Wide Headquarters
Published: 2009-02-12
License: https://open.fda.gov/license/

ZOLL Medical Corporation / initiated 2009-02-12 / Terminated / root cause: manufacturing process

FDA source

ZOLL Medical Corporation, World Wide Headquarters began a recall of Zoll AED Plus Defibrillator on 2009-02-12. The reason FDA records is "Device fails to discharge the defibrillation energy". 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-1206-2009
Status: Terminated
Initiated: 2009-02-12
Posted: 2009-04-01
Terminated: 2026-04-09
Recalling firm: ZOLL Medical Corporation
Product: Zoll AED Plus Defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Device fails to discharge the defibrillation energy.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 3/31/09, the firm revised their recall strategy and required all users to a perform a "Mandatory Upgrade" software The software upgrade allows all potentially affected devices to monitor battery charging performance through periodic self-testing. If defective batteries are detected at any time prior to the recommended maximum of five years, users are prompted by the device to install fresh batteries. Frim issued Press Release on April 2, 2009. In the first notification Zoll notified customers by letter on 2/12/09 via certified mail. Customers instructed to replace device batteries every three years. In lieu of replacing batteries every three years, customers will also have the choice to update their devices with software that will monitor batteries for the identified defect. ZOLL will be send email notification to all consignees who have provided an email address as part of their contact information. ZOLL will also be publishing information of the notification on industry magazines. http://www.zollaedplusbatteryhelp.com/
Quantity in commerce: 183,535 units
Distribution: Worldwide distribution
Product codes and lots: Serial numbers below X_ _ _200000

Product code MKJ

K033474Class IIIZoll AED PlusZoll Medical Corp / cleared 2004-05-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)