Recall Z-0641-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect.
| Date | Nov 9, 2018 |
| Status | Terminated |
| Reason | Issue #1 affects Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2. When an image is flipped horizontally and vertically, the orientation markers appear correctly on the image to which they were applied. However, once new image rendering happens on this image or series (with scrolling; playing cin; maximizing or changing viewports/layouts; or synchronizing viewports and resizing the browser), the new image orientation is correctly maintained but the display of orientation markers can become incorrect. Issue #2 affects Software Versions 6.0 SP7, SP7.0.1, S |
| Root cause | Software design |
| Action | The firm issued the medical device correction notices on 11/09/2018 by letter. The letter outlined the problems and provided work-around strategies to be employed until a product modification is available to correct the issues. |
| Quantity | 508 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131977 | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE Healthcare, Sep 17, 2013 |