FDA Medical Device Recalls (openFDA)
Fujifilm Medical System USA, Inc.: Synapse Version 2.2.1 and 2.3.1 software
- Recall number
- Z-0932-03
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Product
- Synapse Version 2.2.1 and 2.3.1 software
- Status
- Terminated
- Initiated
- 2003-05-12
- Posted
- 2003-06-12
- Terminated
- 2004-05-25
- Reason
- Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan
- Root cause
- Other
- Action
- FujiFilm notified users via letter notification during the week of May 12, 2003. Users wll be visited by a Regional Service Engineer to install the corrected software.
- Quantity
- 54 units
- Distribution
- Nationwide Foreign: Canada, Germany, Israel, Japan
- Lot, serial or model codes
- Verson 2.2.1 and 2.3.1.
- 510(k) numbers
- ["K991257"]
- 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