Synapse Version 2.2.1 and 2.3.1 software
FDA device recall Z-0932-03 · posted 2003-06-12 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Reason for recall
- Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 54 units
- Distribution
- Nationwide Foreign: Canada, Germany, Israel, Japan
- Date initiated
- 2003-05-12
- Date posted
- 2003-06-12
- Date terminated
- 2004-05-25
- Location
- Stamford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION (K991257) | Fujifilm Medical System U.S.A., Inc. | 1999-06-25 |