Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
This recall has been terminated (originally issued December 21, 2004).
- Company
- Philips Medical Systems
- Recall Initiated
- December 15, 2004
- Posted
- December 21, 2004
- Terminated
- February 2, 2016
- Recall Number
- Z-0341-05
- Quantity
- 2520 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy
Distribution
Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen
Lot / Code Info
Software versions A.02.00 and lower
Root Cause
Other
Action Taken
Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative.