FDA Medical Device Recalls (openFDA)
Philips Medical Systems: Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
- Recall number
- Z-0848-05
- Recalling firm
- Philips Medical Systems
- Product
- Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
- Status
- Terminated
- Initiated
- 2005-04-29
- Posted
- 2005-05-17
- Terminated
- 2010-09-14
- Reason
- The device may disarm and not deliver shock when performing a Synchronized Cardioversion
- Root cause
- Software design
- Action
- Philips Medical Systems notified accounts by letter on 5/2/05. The firm provided instructions for identifying the effected devices and actions to be taken until the software is availablel for installation.
- Quantity
- 5125 units
- Distribution
- Nationwide Foreign: Canada, Austria, Australia Bahrain, Belgium, Brazil, China, Hong Kong, India, Finland,France, Germany, Hungry, Israel, Italy, Korea, Kuwait, Latvia, Lebanon, Mexico, Namibia, Libya, Netherland, New Zealnd, Norway, Oma, Philippines, Portugal, Qatat, Russia, South Africa, Singapore Spain, Sweden, Switzerland, Tawian, Thailand, Tunisia, UK, United Arab Emirates, Yemen
- Lot, serial or model codes
- Software Versions A.03.00 or lower and B.04.00 and lower
- 510(k) numbers
- ["K031187"]
- 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