Philips Medical HeartStart MRx Monitor/Defibrillator Model: M3535A, M3536A
- Company
- Philips Medical Systems
- Recall Initiated
- April 29, 2005
- Posted
- May 17, 2005
- Terminated
- September 14, 2010
- Recall Number
- Z-0848-05
- Quantity
- 5125 units
- Firm Location
- Andover, MA
Reason for Recall
The device may disarm and not deliver shock when performing a Synchronized Cardioversion
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 / Code Info
Software Versions A.03.00 or lower and B.04.00 and lower
Root Cause
Software design
Action Taken
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.