Recall Z-0817-05 ยท IXJ Grid, Radiographic
Eastman Kodak Co
KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm
| Date | May 11, 2005 (initiated Apr 8, 2005) |
| Status | Terminated |
| Reason | Screens may be affected with image artifacts |
| Root cause | Other |
| Action | Letters mailed 4/8/2005. Customers informed of the problem and advised that Kodak representatives will exchange the recalled screens for new screens. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925997 | KODAK EKTASCAN SP CASSETTE Eastman Kodak Company, Dec 17, 1992 |