Recall Z-1333-2022 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.
| Date | Jul 5, 2022 (initiated Jun 8, 2022) |
| Status | Open, Classified |
| Reason | Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP) |
| Root cause | Software design |
| Action | GE notified their consignees by issuing an URGENT MEDICAL DEVICE CORRECTION notice on 08 June 2022. The letter explains the two safety issues and provides the following actions be taken: Issue #1: "You can continue to use your device in accordance with the User Manual and the actions below: Do not utilize any measurements when the 'Lossy' overlay is displayed in the lower left of the viewport and, when you hover over the word 'Lossy', it displays the tooltip box with the phrase 'Image scaled down from its original resolution'." Issue #2: "You can continue to use your device in accordance w |
| Quantity | 1,934 units |
| Distribution | Worldwide distribution. |
| 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 |