Z-1182-2007

Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center...

Name: Z-1182-2007 Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center...
Creator: Philips Medical Systems
Published: 2007-07-16
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-07-16 / Terminated

FDA source

Philips Medical Systems began a recall of Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155... on 2007-07-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1182-2007
Status: Terminated
Initiated: 2007-07-16
Posted: 2007-09-05
Terminated: 2016-08-01
Recalling firm: Philips North America LLC
Product: Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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)
FDA root cause: Other
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.
Quantity in commerce: 76 units
Distribution: Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK
Product codes and lots: 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.

Product code MHX

K062271Class IIM3290a Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)Philips Medical Systems / cleared 2006-11-30

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)