Recall Z-1475-2026 ยท LLZ System, Image Processing, Radiological
GE Healthcare
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
| Date | Feb 27, 2026 (initiated Jan 16, 2026) |
| Status | Open, Classified |
| Reason | Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed, |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 01/16/2026 by letter delivered via traceable means. The notice explained the issue and risk, and requested the following: Actions to be taken by Customer/User: "To determine whether you have ZFP Patient Timeline configured at your site, please contact your site administrator. " If you do not have the ZFP Patient Timeline, you can continue to use Centricity Universal Viewer Zero Footprint Client (ZFP) DICOM viewer." "Review all patient studies that were reviewed using the ZFP Patient Timeline to ensure t |
| Quantity | 250 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belarus, Brazil, Canada, China, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Lebanon, Malaysia, Netherlands, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spai |
| 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 |