Recall Z-1782-2017 ยท LLZ System, Image Processing, Radiological
Ge Medical Systems Information T
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
| Date | Apr 11, 2017 (initiated Feb 18, 2013) |
| Status | Terminated |
| Reason | It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder. |
| Root cause | Software design |
| Action | Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue. |
| Quantity | 118 |
| Distribution | Nationwide, Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083018 | CENTRICITY PACS WEB DIAGNOSTIC Ge Healthcare Dynamic Imaging Solutions, Nov 14, 2008 |