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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 04, 2008
Date Posted May 08, 2008
Recall Status1 Terminated 3 on October 07, 2009
Recall Number Z-1141-2008
Recall Event ID 46414
510(K)Number K042292  
Product Classification patient image management system - Product Code LLZ
Product iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
Code Information iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and  3.5.65.0 
Recalling Firm/
Manufacturer		 Philips Healthcare Informatics, Inc.
4100 East Third Avenue
Suite 101
Foster City CA 94404
For Additional Information Contact Steve Kelly
800-722-7900 Ext. 7479
Manufacturer Reason
for Recall		 Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
FDA Determined
Cause 2		 Software design
Action Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.
Quantity in Commerce 197 units
Distribution Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, 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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