FDA Medical Device Recalls (openFDA)
Fujifilm Medical System USA, Inc.: Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
- Recall number
- Z-0622-06
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Product
- Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
- Status
- Terminated
- Initiated
- 2006-02-03
- Posted
- 2006-03-15
- Terminated
- 2012-03-16
- Reason
- Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
- Root cause
- Other
- Action
- FujiFilm Medical Systems USA notified users by letter dated 2/3/06. Users are requested to deactivate the CT Image Processing functionality SWAT (Synapse Web Administration Tool).
- Quantity
- 179 units
- Distribution
- Nationwide Foreign: Canada, Japan, Germany
- Lot, serial or model codes
- Versions 3.1.0 and 3.1.1
- 510(k) numbers
- ["K051553"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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