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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Intellivue Central Station Software

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  Class 2 Device Recall Philips Intellivue Central Station Software see related information
Date Initiated by Firm July 16, 2007
Date Posted September 05, 2007
Recall Status1 Terminated 3 on August 01, 2016
Recall Number Z-1182-2007
Recall Event ID 38400
510(K)Number K062271  
Product Classification Central Station Software - Product Code MHX
Product Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station
Models: M3145, M3150, M3154, M3155, M3169
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Medical Systems
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
978-687-1501
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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