Recall Z-2101-2018 ยท LLZ System, Image Processing, Radiological
GE Healthcare
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
| Date | Jan 25, 2018 |
| Status | Terminated |
| Reason | Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer. |
| Root cause | Software design |
| Action | On January 28, 2019 GE healthcare notified their customers and gave the following instructions for the Centricity Universal Viewer with PACS-IW foundation 6.0.x; GTIN 00840682103800 and Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation.; Until a product modification is available to correct this issue, the following actions are recommended. 1. Utilize the image count within the QC process to alert the user of a discrepancy in the number of transmitted images from the modality to the number of images available in the Universal Viewer. a. If a discrepancy is identifi |
| Quantity | 44 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE Healthcare, Nov 16, 2012 |