Recall Z-3160-2024 ยท LLZ System, Image Processing, Radiological
GE Healthcare
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological image processing system
| Date | Sep 17, 2024 (initiated Jul 23, 2024) |
| Status | Open, Classified |
| Reason | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox. |
| Root cause | Software Design Change |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECITON notice to its consignees on 07/23/2023 via letter. The notice explained the issue, potential risk to the patient, and provided the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions below. Follow one of the below recommendations to ensure the latest addendum is being reviewed: 1. Use Microsoft Edge or Google Chrome browsers when launching ZFP Viewer. OR 2. If you cannot use the browsers listed in #1, t |
| Quantity | 803 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 |