FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0817-05
- Recalling firm
- Eastman Kodak Co
- 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
- Status
- Terminated
- Initiated
- 2005-04-08
- Posted
- 2005-05-11
- Terminated
- 2005-12-19
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K925997"]
- PMA numbers
- not on file
- Product code
- IXJ
- Firm FEI
- 1315356
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28