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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 December 20, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = STENTOR, INC.
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