FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
- Recall number
- Z-1128-2007
- Recalling firm
- Philips Medical Systems
- Product
- Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
- Status
- Terminated
- Initiated
- 2007-06-11
- Posted
- 2007-08-07
- Terminated
- 2016-08-08
- Reason
- The ECG signal may become unusable to assess patient condition and need for therapy.
- Root cause
- Nonconforming Material/Component
- Action
- Philips Medical contacted accounts by letter dated June 11, 2007. Users are advised to remove product from service, if possible. If not, a back up unit should be available to use. Service reps will contact accounts to replace units.
- Quantity
- 312 units
- Distribution
- Worldwide, including USA, Canada, Australia, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Kuwait, Macau, Poland, Portugal, Romania, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, UK, and Venezuela.
- Lot, serial or model codes
- Serial Numbers: US00453441 through US00453910
- 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