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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Informatics iSite PACS

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  Class 2 Device Recall Philips Healthcare Informatics iSite PACS see related information
Date Initiated by Firm July 03, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on October 07, 2009
Recall Number Z-2346-2008
Recall Event ID 48986
510(K)Number K042292  
Product Classification Picture Archiving and Communication System - Product Code LLZ
Product Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x
The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
Code Information all products with software versions 3.5.x
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		 Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
FDA Determined
Cause 2		 Software design
Action A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.
Quantity in Commerce 198 systems
Distribution Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria
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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