Recall Z-1886-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product 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
| Date | May 17, 2019 |
| Status | Terminated |
| Reason | There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer. |
| Root cause | Software design |
| Action | The firm issued a medical device correction notice on 05/17/2019. The letter stated the safety issue and provided additional instructions on the use of the system until a service engineer installs the correction. A firm representative will contact the consignee to arrange for the installation. |
| Quantity | 292 units |
| Distribution | Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150420 | Centricity Universal Viewer GE Healthcare, May 26, 2015 |