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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACS software

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 Class 2 Device Recall GE Centricity PACS softwaresee related information
Date Initiated by FirmApril 03, 2009
Date PostedJuly 01, 2009
Recall Status1 Terminated 3 on May 25, 2012
Recall NumberZ-1549-2009
Recall Event ID 51501
510(K)NumberK043415 
Product Classification System, image processing, radiological - Product Code LLZ
ProductGE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment.
Code Information Centricity PACS software versions 2.1.X and 3.0.X and Centricity PACS versions 1.0.X and 2.0.X.
FEI Number 3004526608
Recalling Firm/
Manufacturer		 GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information ContactGE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.
FDA Determined
Cause 2		Software design
ActionGE Healthcare Integrated IT Solutions sent an "Urgent Medical Device Correction" letter dated April 2, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers with attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the patient safety issue associated with the affected device and provided safety instructions to follow until the software is updated. User were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issue and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.
Quantity in Commerce1,188 units
DistributionWorldwide Distribution - United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LLZ
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