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U.S. Department of Health and Human Services

Class 2 Device Recall Philips IntelliSpace PACS 4.4 Image Management Systems

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 Class 2 Device Recall Philips IntelliSpace PACS 4.4 Image Management Systemssee related information
Date Initiated by FirmJuly 24, 2014
Date PostedAugust 16, 2014
Recall Status1 Terminated 3 on February 11, 2016
Recall NumberZ-2252-2014
Recall Event ID 68979
510(K)NumberK111804 
Product Classification System, image processing, radiological - Product Code LLZ
ProductPhilips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Code Information IntelliSpace 4.4
Recalling Firm/
Manufacturer		 Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City CA 94404-4819
For Additional Information ContactDeana Wiseman
650-293-2659
Manufacturer Reason
for Recall		A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
FDA Determined
Cause 2		Software design
ActionUrgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.
Quantity in Commerce109 units
DistributionUS and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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