Recall Z-0622-06 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical System USA, Inc.
Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
| Date | Mar 15, 2006 (initiated Feb 3, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051553 | FUJI SYNAPSE WORKSTATION SOFTWARE Fujifilm Medical Systems U.S.A, Inc., Jul 7, 2005 |