FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1585-2015
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
- Status
- Terminated
- Initiated
- 2015-02-03
- Posted
- 2015-05-06
- Terminated
- 2015-05-20
- 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.
- Lot, serial or model codes
- Serial Number: 26320119
- 510(k) numbers
- ["K110729"]
- PMA numbers
- not on file
- Product code
- MUE
- Firm FEI
- 1000513161
- Firm city
- Stamford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28