RecallDepth

Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)

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

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.

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