Recall Z-0039-2025 ยท LLZ System, Image Processing, Radiological
GE Healthcare
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 2089507-120; b) 2089507-129; c) 2089507-131; d) 2089507-135; e) 2089507-136; f) 2089507-140; g) 2089507-144; h) 2089507-145; i) 2089507-149; j) 2089507-153; k) 2089507-154; l) 2089507-155; m) 2089507-156; n) 2089507-157; o) K2037DAED; p) K2037DBED; q) K2037DED; r) K2037DJED; s) K2037
| Date | Oct 9, 2024 (initiated Aug 29, 2024) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study has multiple DICOM structured reports (i.e. preliminary, final, and/or addendum) stored in different series. |
| Root cause | Process control |
| Action | GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 08/29/2024 via mail. The notice explained the issue with the device, safety issue, and provided the following: "Actions to be taken by Customer/User: You can continue to use your device by following the recommendation below. To find the latest report, review all the reports available for the study in the Series Selector. Navigation to the series selection can be found in the User Manual under Section 2.4.3 of The Series Selector, with the subheading of Open a report/document. Please ensure all potential |
| Quantity | 1500 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 |