Reported Jun 13, 2018 · Terminated
Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device…
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 Product UsageUsage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants
- Lot codes and dates
- 102747-1-Centricity Universal Viewer-00558673, 11580-1-Centricity Universal Viewer-00558646, 12945-1-Centricity Universal Viewer-00558658, 103852-1-Centricity Universal Viewer-00116028, 103246-1-Centricity Universal Viewer-00558668, 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 101725-2-Centricity Universal Viewer-00558642, 10227-1-Centricity Universal Viewer-00558665, 9768-1-Centricity Universal Viewer-00558661, 100019-1-Centricity Universal Viewer-00558666, 4284-1-Centricity Universal Viewer-00558672, 101272-1-Centricity Universal Viewer-00558671, 100862-1-Centricity Universal Viewer-01444483, 10278-1-Centricity Universal Viewer-00558655, 9789-1-Centricity Universal Viewer-00558645, 12914-1-Centricity Universal Viewer-00558660, 1696-1-Centricity Universal Viewer-00558659, 4408-1-Centricity Universal Viewer-00558664, 4410-1-Centricity Universal Viewer-00558656, 4407-1-Centricity Universal Viewer-00558657, 4407-1-Centricity Universal Viewer-00558652, 4405-1-Centricity Universal Viewer-00558662, 4546-1-Centricity Universal Viewer-00558670, 100064-1-Centricity Universal Viewer-00558572, 100092-1-Centricity Universal ,Viewer-00558648, 1345-1-Centricity Universal Viewer-00558654, 4705-1-Centricity Universal Viewer-00558663, 4418-1-Centricity Universal Viewer-00558674, 102062-1-Centricity Universal Viewer-00558650, 12866-1-Centricity Universal Viewer-01448215, 101931-1-Centricity Universal Viewer-00558569, 4601-1-Centricity Universal Viewer-00558710, 102406-2-Centricity Universal Viewer-00558669, 102406-2-Centricity Universal Viewer-00558667 A59927-Centricity Universal Viewer-00040382, X13479-Centricity Universal Viewer-00043936, and 269338-Centricity Universal Viewer-01453050, 94767-Centricity Universal Viewer-01422997.
- Amount recalled
- 44
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
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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