Z-0817-05

KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label...

Name: Z-0817-05 KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label...
Creator: Eastman Kodak Co
Published: 2005-04-08
License: https://open.fda.gov/license/

Eastman Kodak Company / initiated 2005-04-08 / Terminated

FDA source

Eastman Kodak Co began a recall of 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... on 2005-04-08. The reason FDA records is "Screens may be affected with image artifacts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0817-05
Status: Terminated
Initiated: 2005-04-08
Posted: 2005-05-11
Terminated: 2005-12-19
Recalling firm: Eastman Kodak Company
Product: 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
Product code: IXJ Grid, Radiographic
Reason for recall: Screens may be affected with image artifacts
FDA 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 in commerce: 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.
Product codes and lots: Each screen has a 17-digit code. Product subject to recall includes ALL codes containing ''CE'' and ''CR'' and codes with ''CO'' with date code of ''051'' or lower. NOTE: The date codes are the 8th thru 10th digit and equal the julian date. The YEAR CODES are the 11th and 12th digit. The codes are located at the top edge of the CR screen. i.e. xxxxxxx051CO#xxxx.

Product code IXJ

K925997Class IKodak Ektascan Sp CassetteEastman Kodak Company / cleared 1992-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)