Fuji Flash IIP and CR-IR346CL Consoles
FDA device recall Z-0993-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Fujifilm Medical System USA, Inc.
- Reason for recall
- Software: Incorrect measurement of objects within a CR image
- Action taken
- FujiFilm Medical Systems issued notification letter dated 5/5/04 via Certified Mail. Units will be field corrected with a revised software by a service representative.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 2602 units
- Distribution
- Nationwide
- Date initiated
- 2004-05-05
- Date posted
- 2004-07-20
- Date terminated
- 2005-04-20
- 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 SPEED SUITE, FUJI SPEED SUTE PHASE II (K013218) | Fujifilm Medical System U.S.A., Inc. | 2001-12-20 |