Recall record at a glance
| Official record | Z-2102-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | Jun 13, 2018 |
| Recall initiation date | Jan 25, 2018 |
| Quantity | 252 |
| Location | Chicago, IL, United States |
Official product description
Centricity 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 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.
Why the product was recalled
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
Distribution information
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, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, Panama, Poland, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdomand Uruguay
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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