Recall Z-0374-2019 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
| Date | Oct 11, 2018 |
| Status | Terminated |
| Reason | Synchronization failure |
| Root cause | Software design |
| Action | On October 12, 2018 GE Healthcare send recall notification to all their consignees with the following instructions; If you do not use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, your system is not affected by the safety issue. If you do use a Diagnostic viewer (e.g. Centricity Universal Viewer Zero Footprint Client or any 3rd party dicom viewer) connected directly to the same Centricity EA to display images for diagnostic purposes, please conta |
| Quantity | 13 |
| Distribution | CA, CO, DE, FL, HI, NY, OK, PA, SD, TX, WA, WI, and WV Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, Ireland, Italy, Mexico, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Switzerland, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE Healthcare, Nov 16, 2012 |