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U.S. Department of Health and Human Services

Class 2 Device Recall iSite PACS

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 Class 2 Recall
iSite PACS
see related information
Date Posted March 13, 2007
Recall Status1 Terminated on December 03, 2007
Recall Number Z-0616-2007
Recall Event ID 37479
Premarket Notification
510(K) Number
K042292 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment.
Code Information Version 3.5
Recalling Firm/
Manufacturer
Stentor Inc A Phillips Medical Systems Co.
4100 East Third Ave Suite 101
Foster City, California 94404
Manufacturer Reason
for Recall
A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.
Quantity in Commerce 54 units
Distribution Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.
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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