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U.S. Department of Health and Human Services

Class 2 Device Recall iSite PACS software versions 3.6.28.x and 4.1.x.

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 Class 2 Recall
iSite PACS software versions 3.6.28.x and 4.1.x.
see related information
Date Posted October 28, 2008
Recall Status1 Open
Recall Number Z-0118-2009
Recall Event ID 49403
Premarket Notification
510(K) Numbers
K042292  K063267 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
Code Information Software versions 3.6.28.x and 4.1.x.
Recalling Firm/
Manufacturer
Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City, California 94404-4819
Manufacturer Reason
for Recall
Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot
FDA Determined
Cause 2
DESIGN: Software Design
Action A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.
Quantity in Commerce 27 units.
Distribution Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO.
510(K)s with Product Code = LLZ and Original Applicant = STENTOR, INC.
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