Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening
FDA device recall Z-1585-2015 · posted 2015-05-06 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Reason for recall
- User Manual lacks a description for handling some errors even though the system can be recovered from such errors
- Action taken
- 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 .
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- MUE
- Quantity affected
- 1 unit
- Distribution
- Distributed in HI.
- Date initiated
- 2015-02-03
- Date posted
- 2015-05-06
- Date terminated
- 2015-05-20
- Location
- Stamford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM (K110729) | Fujifilm Medical Systems U.S.A, Inc. | 2011-09-01 |