GE Healthcare Recall: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centr
GE Healthcare Recall: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centr is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: GE Healthcare; Product: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that di
| Recalling firm | GE Healthcare |
|---|---|
| Product | Centricity PACS-IW with Universal Viewer Product Usage: Usage: 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 |
| Reason for recall | Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Irela |
| Recall initiated | 20180125 |
| Recall number | Z-2101-2018 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
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