RecallDepth

Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169

Company
Philips Medical Systems
Recall Initiated
July 16, 2007
Posted
September 5, 2007
Terminated
August 1, 2016
Recall Number
Z-1182-2007
Quantity
76 units
Firm Location
Andover, MA

Reason for Recall

Incorrect Patient Assignment: the information center will in most cases be associated with the "incorrect" patient. This occurs on both standalone and networked systems running fixed mode monitoring. (This does not occur on systems that run flex mode monitoring)

Distribution

Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK

Lot / Code Info

Software versions: J.00.23 and J.00.24 (You can determine the application software release as follows: 1-Enter Service Mode through "All Controls" , "Service" 2-Under the "Other Services " menu item, click "Software Versions" 3-"Application" lists the application software version.

Root Cause

Other

Action Taken

Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made.

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