Recall Z-1585-2015 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Fujifilm Medical Systems U.S.A., Inc.
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
| Date | May 6, 2015 (initiated Feb 3, 2015) |
| Status | Terminated |
| Reason | User Manual lacks a description for handling some errors even though the system can be recovered from such errors |
| Root cause | Labeling Change Control |
| Action | Fuji Film on 2/3/15, issued a User Notification letter and the recovery procedure were hand carried to the user. A copy of Notification Letter is user's acknowledgement of receipt of the manual . |
| Quantity | 1 unit |
| Distribution | Distributed in HI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110729 | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM Fujifilm Medical Systems U.S.A, Inc., Sep 1, 2011 |