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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACS (Versions 3.1.1.2 or later)

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 Class 2 Recall
GE Centricity PACS (Versions 3.1.1.2 or later)
see related information
Date Posted January 14, 2014
Recall Status1 Open
Recall Number Z-0731-2014
Recall Event ID 64724
Premarket Notification
510(K) Number
K043415 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. the workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
Code Information GE Centricity Software versions 3.X and higher and 4.X and higher
Recalling Firm/
Manufacturer
Ge Healthcare It
540 W Northwest Hwy
Barrington, Illinois 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall
There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X and higher and 4.X and higher when transferring from the source to a destination server. When another process in the destination server attempts to access the same object or table, the transfer process of a particular image may be terminated. Once ter
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare sent an Important Product Information letter dated September 15, 2012 to affected customers. The letter identified the affected product problem and actions to be taken. GE Healthcare will provide a patch to 3.2.X and 4.0 Systems to remediate the issue. For questions contact your local GEHC-IT service representative.
Quantity in Commerce 748 units
Distribution Worldwide Distribution - US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY); FOREIGN: Australia, Austria, Belgium, Bermuda, China, Denmark, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Malta, Netherlands, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
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 = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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