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U.S. Department of Health and Human Services

Class 2 Device Recall iSite PACS

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  Class 2 Device Recall iSite PACS see related information
Date Initiated by Firm February 14, 2007
Date Posted March 13, 2007
Recall Status1 Terminated 3 on December 03, 2007
Recall Number Z-0616-2007
Recall Event ID 37479
510(K)Number K042292  
Product Classification Image Processing System-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 CA 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		 Other
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 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) Database 510(K)s with Product Code = LLZ and Original Applicant = STENTOR, INC.
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