Recall Z-0932-03 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical System USA, Inc.
Synapse Version 2.2.1 and 2.3.1 software
| Date | Jun 12, 2003 (initiated May 12, 2003) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991257 | FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION Fujifilm Medical System U.S.A., Inc., Jun 25, 1999 |