Recall Z-0386-2018 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Fujifilm Medical Systems U.S.A., Inc.
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film
| Date | Jan 17, 2018 (initiated Jul 14, 2017) |
| Status | Terminated |
| Reason | There was a case that the swivel arm went down unintentionally when it was moved up/down. |
| Root cause | Employee error |
| Action | FUJIFILM sent an Urgent: Medical Device Correction Letter dated July 14, 2017, accompanied by a Customer Feedback form to customers. PLEASE READ AND FOLLOW THE INSTRUCTIONS Please refer to the following page which provides the details of the problem and instructions for actions to be taken. Please follow the instructions in the ACTIONS TO BE TAKEN BY CUSTOMER/USER section. We sincerely regret the inconvenience that this may cause you. FUJIFILM is committed to providing products and services of the highest quality. Your satisfaction with FUJIFILM products and with our response to this issue |
| Quantity | 15 US 1 OUS |
| Distribution | US Distribution and Internationally to Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133972 | ASPIRE CRISTALLE Fujifilm Medical Systems U.S.A, Inc., Mar 25, 2014 |