Reported Oct 14, 2015 · Terminated
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including…
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?
- Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
- Lot codes and dates
- GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1
- Amount recalled
- 921 systems are impacted.
Where it was sold
Why it was recalled
Images may be missing when a system parameter MapRoute is set to a value greater than 1.
This product could cause temporary or reversible health problems — stop using it.
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