Company: Ge Healthcare It
Date of Enforcement Report 8/24/2016
Class lI:
PRODUCT
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.
Recall Number Z-23579-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Ge Healthcare IT, Barrington, IL Recall Initiation Date:11/15/2012. Center Classification Date:
08/17/2016 Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
498 units
DISTRIBUTION
Nationwide and Internationally
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