Reported Nov 6, 2013 · Terminated
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including…
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?
- 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. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
- Lot codes and dates
- Software Versions
3.7.13.7.1.13.7.23.7.3.13.7.3.33.7.3.43.7.3.53.7.6.33.7.3.7and 3.7.3.8
- Software Versions
- Amount recalled
- 847 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe
This product could cause temporary or reversible health problems — stop using it.
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