—#53538

Product

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

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K062271
Affected 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.

Why it was recalled

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)

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

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

Timeline

Recall initiated: 2007-07-16
Posted by FDA: 2007-09-05
Terminated: 2016-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53538. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.