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Terminated

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

FDA Recall Z-1182-2007 · Posted 2007-09-05

Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeMHX
Date Initiated2007-07-16
Date Terminated2016-08-01
Product Quantity76 units

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)

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062271M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)Philips Medical Systems · 2006-11-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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