FDA Medical Device Recalls (openFDA)
ZOLL Medical Corporation, World Wide Headquarters: Zoll AED Plus Defibrillator
- Recall number
- Z-1206-2009
- Recalling firm
- ZOLL Medical Corporation, World Wide Headquarters
- Product
- Zoll AED Plus Defibrillator
- Status
- Terminated
- Initiated
- 2009-02-12
- Posted
- 2009-04-01
- Terminated
- 2026-04-09
- Reason
- Device fails to discharge the defibrillation energy.
- 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
- 183,535 units
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- Serial numbers below X_ _ _200000
- 510(k) numbers
- ["K033474"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1220908
- Firm city
- Chelmsford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28