FDA Medical Device Recalls (openFDA)
Zoll Medical Corporation: Zoll AED Plus Defibrillator (Automatic External Defibrillator)
- Recall number
- Z-0548-03
- Recalling firm
- Zoll Medical Corporation
- Product
- Zoll AED Plus Defibrillator (Automatic External Defibrillator)
- Status
- Terminated
- Initiated
- 2002-12-17
- Posted
- 2003-02-06
- Terminated
- 2004-04-21
- Reason
- Defibrillator may fail to function due to false detection of safety fault condition
- 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
- 5,597 units
- Distribution
- Nationwide to : Hospitals, EMT, Police and Fire Rescue
- Lot, serial or model codes
- Serial Numbers: X02F000812 through X02K007486
- 510(k) numbers
- ["K011388"]
- 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