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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 January 29, 2008
Date Posted August 16, 2008
Recall Status1 Terminated 3 on September 25, 2008
Recall Number Z-1444-2008
Recall Event ID 46942
510(K)Number K063267  
Product Classification Image Management System - Product Code LLZ
Product Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
Code Information Version 4.1.17.0
Recalling Firm/
Manufacturer		 Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City CA 94404-4819
For Additional Information Contact
650-293-2624
Manufacturer Reason
for Recall		 When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool.
FDA Determined
Cause 2		 Software design
Action The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.
Quantity in Commerce 2 units
Distribution Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
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., A PHILIPS MEDICAL SYSTEMS CO.
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