FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
- Recall number
- Z-0432-2011
- Recalling firm
- Philips Medical Systems
- Product
- Philips HeartStart FRx Defibrillator, Automated External Defibrillator (AED), catalog number 861304.
- Status
- Terminated
- Initiated
- 2008-08-07
- Posted
- 2010-11-22
- Terminated
- 2010-12-01
- Reason
- The affected device may not deliver appropriate defibrillation therapy.
- Root cause
- Employee error
- Action
- Philips notified the customer with the affected device by phone on August 8, 2008 . A replacement device was shipped to the customer on August 11, 2008.
- Quantity
- 1 unit
- Distribution
- Nationwide Distribution: to one account in Arkansas.
- Lot, serial or model codes
- Serial Number: B08G-01884
- 510(k) numbers
- ["K050004"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1000524572
- Firm city
- Seattle
- Firm state
- WA
- 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