Reported Jun 4, 2014 · Terminated
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by…
GE Healthcare
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 · 540 W Northwest Hwy · Barrington, IL · 60010-3051
Is this the product you have?
- The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, 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 wit the Centricity PACS infrastructure.
- Lot codes and dates
- Centricity PACS versions
3.23.2.0.13.2.0.23.2.13.2.23.2.2.13.2.2.23.2.2.33.2.63.2 SP73.2 SP84.04.0.14.0 SP3
- Centricity PACS versions
- Amount recalled
- 297 units
Where it was sold
Why it was recalled
It has been identified that in a reject image workflow where multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for the previously displayed study may also be rejected. The issue can occur with a previously displayed study that remains open in the background. If one or more, but not all, images in
This product could cause temporary or reversible health problems — stop using it.
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