Recall Z-1566-2022 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
| Date | Aug 24, 2022 (initiated Jul 15, 2022) |
| Status | Open, Classified |
| Reason | Inaccurate Distance and Area measurements with use of Global Stack viewport. |
| Root cause | Process design |
| Action | The recalling firm issued letters dated 7/15/2022 via traceable means on 7/15/2022 to the following titles within their affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics. The letter explained the issue, the affected product details, and the actions to be taken by the customer/user, which included the following: The customer/user can continue to use the syste |
| Quantity | 1,690 devices |
| Distribution | Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, A |
| FDA record | Open on fda.gov |