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Terminated

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

FDA Recall Z-0817-05 · Posted 2005-05-11

Recalling FirmEastman Kodak Co
Recall StatusTerminated
Product CodeIXJ
Date Initiated2005-04-08
Date Terminated2005-12-19
Product QuantityApproximately 6,900 screens

Reason for Recall

Screens may be affected with image artifacts

Firm Action

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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K925997KODAK EKTASCAN SP CASSETTEEastman Kodak Company · 1992-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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