Class 2 Device Recall iSite PACS

• Date Initiated by Firm: February 14, 2007
• Date Posted: March 13, 2007
• Recall Status: Terminated 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: 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