Reported Aug 24, 2016 · Terminated
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a…
GE Healthcare It
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare It · 540 W Northwest Hwy · Barrington, IL · 60010-3051
Is this the product you have?
- 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.
- Lot codes and dates
- Centricity PACS versions 3.1.1.x through 3.2.1.x
- Amount recalled
- 498 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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