Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
FDA device recall Z-0622-06 · posted 2006-03-15 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Reason for recall
- Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
- Action taken
- 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).
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 179 units
- Distribution
- Nationwide Foreign: Canada, Japan, Germany
- Date initiated
- 2006-02-03
- Date posted
- 2006-03-15
- Date terminated
- 2012-03-16
- 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 |
|---|---|---|
| FUJI SYNAPSE WORKSTATION SOFTWARE (K051553) | Fujifilm Medical Systems U.S.A, Inc. | 2005-07-07 |