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U.S. Department of Health and Human Services

Class 2 Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3

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 Class 2 Recall
iSite PACS Versions 4.1.x up to and including 4.1.51.3
see related information
Date Posted January 30, 2009
Recall Status1 Open
Recall Number Z-0948-2009
Recall Event ID 50751
Premarket Notification
510(K) Number
K063267 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management system intended to be used by trained professionals, and 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 image processing, measurement, communication and storage
Code Information Versions 4.1.x up to and including 4.1.51.3
Recalling Firm/
Manufacturer
Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City, California 94404-4819
Manufacturer Reason
for Recall
Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.
FDA Determined
Cause 2
DESIGN: Software Design
Action Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624.
Quantity in Commerce 40 units
Distribution International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
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., A PHILIPS MEDICAL SYSTEMS CO.
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