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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Informatics iSite PACS

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 Class 2 Recall
Philips Healthcare Informatics iSite PACS
see related information
Date Posted September 18, 2008
Recall Status1 Terminated on October 07, 2009
Recall Number Z-2346-2008
Recall Event ID 48986
Premarket Notification
510(K) Number
K042292 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
Code Information all products with software versions 3.5.x
Recalling Firm/
Manufacturer
Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City, California 94404-4819
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
FDA Determined
Cause 2
DESIGN: Software Design
Action A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.
Quantity in Commerce 198 systems
Distribution Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = STENTOR, INC.
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