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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACSIW Software

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  Class 2 Device Recall GE Centricity PACSIW Software see related information
Date Initiated by Firm February 18, 2010
Date Posted April 15, 2010
Recall Status1 Terminated 3 on June 10, 2016
Recall Number Z-1394-2010
Recall Event ID 55040
510(K)Number K082318  
Product Classification system, image processing, radiological - Product Code LLZ
Product GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.

The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Code Information Software version 3.x
Recalling Firm/
Manufacturer		 Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		 There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.
FDA Determined
Cause 2		 Software design
Action An "Urgent Medical Device Correction" letters dated February 18, 2010 to their Centricity PACS-IW software version 3.x customers and Centricity PACS Web Diagnostic software version 3.7.4.x customers, The letters advised the users of the patient safety issues associated with the use of the software when using built-in reconstruction functions, which may result in incorrect anatomic orientation markers. The separate letters provided the users with specific safety instructions for that software version to follow until the software is updated. The customers were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.
Quantity in Commerce 634 units
Distribution Worldwide distribution: USA and Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Netherlands, Philippines, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom.
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 = GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
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