Recall Z-0819-2020 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
| Date | Jan 17, 2020 (initiated Dec 16, 2019) |
| Status | Terminated |
| Reason | Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis. |
| Root cause | Software design |
| Action | The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue. |
| Quantity | 205 |
| Distribution | Distributed nationwide; Internationally distributed to Mexico and 24 additional countries. |
| FDA record | Open on fda.gov |