Reported Nov 1, 2023 · Ongoing
Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
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 · 500 W Monroe St · Chicago, IL · 60661-3671
Is this the product you have?
- Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
- Lot codes and dates
- UDI/DI none, Installed Product ID #: 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785, 100759-1-Centricity Universal Viewer-02360986, 9842-4-Centricity Universal Viewer-19386293, 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 4705-1-Centricity Universal Viewer-02398923, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, HC3062-Centricity Universal Viewer-01462397, RU9761-UW PACS-IW UP TO 10K-02336112, ZA2533-Centricity Universal Viewer-00116577, YP3150-Centricity Universal Viewer-01639018
- Amount recalled
- 17 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
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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