KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S
FDA device recall Z-0817-05 · posted 2005-05-11 · Terminated
Recall details
- Recalling firm
- Eastman Kodak Co
- Reason for recall
- Screens may be affected with image artifacts
- Action taken
- Letters mailed 4/8/2005. Customers informed of the problem and advised that Kodak representatives will exchange the recalled screens for new screens.
- Root cause
- Other
- Status
- Terminated
- Product code
- IXJ
- Quantity affected
- Approximately 6,900 screens
- Distribution
- There are 263 U.S. customers; 22 Canadian customers; 74 Japanese customers; 213 Greater Asian Region customers; 19 Latin American customers; 306 Europe/Africa/ Middle East customers.
- Date initiated
- 2005-04-08
- Date posted
- 2005-05-11
- Date terminated
- 2005-12-19
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KODAK EKTASCAN SP CASSETTE (K925997) | Eastman Kodak Company | 1992-12-17 |