| Date Initiated by Firm | May 05, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on April 20, 2005 |
| Recall Number | Z-0993-04 |
|---|
| Recall Event ID |
29066 |
| 510(K)Number | K013218 |
|---|
| Product Classification |
Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
|
| Product | Fuji Flash IIP and CR-IR346CL Consoles |
|---|
| Code Information |
Versions A09-17 through A11-12 |
| FEI Number |
1000513161
|
Recalling Firm/
Manufacturer |
Fujifilm Medical System USA, Inc.
419 West Ave
Stamford CT 06902-6300
|
| For Additional Information Contact | Frank Gianelli
203-602-3774 |
|---|
Manufacturer Reason
for Recall | Software: Incorrect measurement of objects within a CR image |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 2602 units |
|---|
| Distribution | Nationwide |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MQB
|
|---|
