GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used 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.
FDA Recall Z-2579-2016 · Posted None
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Recalling FirmGE Healthcare It
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-11-15
Date Terminated2017-12-13
Product Quantity498 units
Reason for Recall
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager.
When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
Firm Action
GE sent an Urgent Medical Device Correction letter dated November 15, 2012. The software has been modified to correct these defects. The modified software was released and installed in user sites under GE Healthcare FMI #85196.
Root Cause
Software design
Distribution Pattern
Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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