Class 2 Device Recall ISite PACS

• Date Initiated by Firm: December 20, 2005
• Date Posted: January 18, 2006
• Recall Status: Terminated on April 14, 2006
• Recall Number: Z-0399-06
• Recall Event ID: 34270
• 510(K)Number: K042292
• Product Classification: System, Image Processing, Radiological - Product Code LLZ
• Product: ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
• Code Information: All models, version 3.3
• FEI Number: 3002971142
• Recalling Firm/ Manufacturer: Stentor Inc; 5000 Marina Blvd; Brisbane CA 94005-1330
• For Additional Information Contact: Deana Wiseman; 650-228-5402
• Manufacturer Reason for Recall: When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens
• FDA Determined Cause: Other
• Action: On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
• Quantity in Commerce: 110 units
• Distribution: Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
• 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