Recall Z-2690-2016 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Fujifilm Medical Systems U.S.A., Inc.
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional scr
| Date | Jun 9, 2016 |
| Status | Terminated |
| Reason | If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system from continuing to operate properly. |
| Root cause | Software design |
| Action | The firm, Fujifilm, sent a "FIELD SAFETY NOTICE" letter dated June 9, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to read and follow the instructions in the letter; call your local service representative, in case an error occurs, and complete and return the Customer Feedback Form via fax (203)-251-7862. Both affected systems will be corrected via on-site visits by FMSU Customer Service Engineers. If you have any questions about this matter, please contact the Product Manager, Women's Health directl |
| Quantity | 2 Units |
| Distribution | US Distribution to: NC and HI. |
| FDA record | Open on fda.gov |