FDA Medical Device Recalls (openFDA)
Fujifilm Medical System USA, Inc.: Fuji Flash IIP and CR-IR346CL Consoles
- Recall number
- Z-0993-04
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Product
- Fuji Flash IIP and CR-IR346CL Consoles
- Status
- Terminated
- Initiated
- 2004-05-05
- Posted
- 2004-07-20
- Terminated
- 2005-04-20
- Reason
- Software: Incorrect measurement of objects within a CR image
- Root cause
- Other
- Action
- FujiFilm Medical Systems issued notification letter dated 5/5/04 via Certified Mail. Units will be field corrected with a revised software by a service representative.
- Quantity
- 2602 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Versions A09-17 through A11-12
- 510(k) numbers
- ["K013218"]
- PMA numbers
- not on file
- Product code
- MQB
- 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