FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Model M4735A HeartStart XL Defibrillator//Monitor
- Recall number
- Z-1226-03
- Recalling firm
- Philips Medical Systems
- Product
- Model M4735A HeartStart XL Defibrillator//Monitor
- Status
- Terminated
- Initiated
- 2003-09-02
- Posted
- 2003-09-11
- Terminated
- 2005-04-20
- Reason
- Instructions For Use include addtional information on configuration for selecting Power on Lead
- Root cause
- Other
- Action
- Philips Medical in conjunction with NNC (National Notification Center) notified users by letter on 9/2/03. Users are provided with Addendum to the HeartStart XL Instructions for Use (to be added to the Instruction for Use) and to familiarize with the configurable Power on Lead. Users are rquested to acknowledge receipt by returning the Business reply Card.
- Quantity
- 16,736 units
- Distribution
- NATIONWIDE Foreign: Canada, Argentina, Brazil, Chile, Costa Rica, Mexico, Paraguay, Peru, Venezuela, Austalia, China,Hong Kong, India, Japan, Malaysia, Manilla, New Zealand, Manila, Singapore,Taiwan,Thailand, Vietnam, ALgeria, Australia,France,Italy, Netherlands,Norway,Oman,Poland, Portugal,South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tunisia, Turkey, UK
- Lot, serial or model codes
- Units with software versions A.02.00 or greater
- 510(k) numbers
- ["K021453"]
- PMA numbers
- not on file
- Product code
- MKJ
- Firm FEI
- 1218950
- Firm city
- Andover
- 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