Reported Nov 14, 2018 · Terminated
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including…
GE Healthcare, LLC
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, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
- Lot codes and dates
- 102062-1-Centricity Universal Viewer-00558650/1-357058918; 102406-2-Centricity Universal Viewer-00558667/1-640193933; 102406-2-Centricity Universal Viewer-00558669/1-598891571; 102747-1-Centricity Universal Viewer-00558673 /1-626086029; 103246-1-Centricity Universal Viewer-00558668 / 1-681512983; 11580-1-Centricity Universal Viewer-00558646 / 1-417869653; 2403-7-Centricity Universal Viewer-00558347 1-283597082; 269338-Centricity Universal Viewer-01453050 /HCIT4331279PIW; 4284-1-Centricity Universal Viewer-00558672 / 1-308060186; 4424-2-Centricity Universal Viewer-01474435 / CONCORDIM01474435; Installation tracked via System ID. / HCIT4216808PIW; Installation tracked via System ID. / 2UA443117XAW; and X13479-Centricity Universal Viewer-00043936 / X1347906 / X1347909.
- Amount recalled
- 13
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
Synchronization failure
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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