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Class 2 Device Recall iSite PACS Versions 4.1.x up to and including 4.1.51.3 |
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Date Initiated by Firm |
December 29, 2008 |
Date Posted |
January 30, 2009 |
Recall Status1 |
Terminated 3 on November 29, 2010 |
Recall Number |
Z-0948-2009 |
Recall Event ID |
50751 |
510(K)Number |
K063267
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Product Classification |
Picture Archiving and Communications System - Product Code LLZ
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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 CA 94404-4819
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For Additional Information Contact |
650-293-2624
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO.
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