FDA Medical Device Recalls (openFDA)
Zoll Medical Corporation: Zoll M Series External Defibrillator
- Recall number
- Z-1000-03
- Recalling firm
- Zoll Medical Corporation
- Product
- Zoll M Series External Defibrillator
- Status
- Terminated
- Initiated
- 2003-06-23
- Posted
- 2003-07-10
- Terminated
- 2020-12-29
- Reason
- Defibrillator may fail to charge or hold its charge above energies of 75 joules
- 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
- 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,
- Lot, serial or model codes
- Serial Numbers: T02I37097-T03C45238
- 510(k) numbers
- ["K972241"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1220908
- Firm city
- Burlington
- 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