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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 11, 2010
Date Posted April 16, 2010
Recall Status1 Terminated 3 on November 15, 2010
Recall Number Z-1402-2010
Recall Event ID 55037
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.

Device that receives, stores and communicates medical images and data from various imaging sources.
Code Information Software version 3.7.3
Recalling Firm/
Ge Healthcare It
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact GE Customer Care Center
Manufacturer Reason
for Recall
There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software when dragging-and-dropping images from the Navigator causing flipping of the images that may impact patient safety.
FDA Determined
Cause 2
Software design (manufacturing process)
Action GE Healthcare issued "Urgent Medical Device Correction" notifications dated February 11, 2010. The initial notification advised users of the patient safety issues associated with the affected product. Separate letters provided the users with specific safety instructions. Accounts 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. For additional information, contact the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.
Quantity in Commerce 29 units
Distribution Worldwide Distribution -- United States (California, Illinois, Indiana, Minnesota, Nevada, New York and Wisconsin), Austria, Canada, Finland, France, Germany, Ireland, Lebanon, Japan, Philippines, Saudi Arabia, Singapore, Switzerland, Turkey, United Arab Emirates and the 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