FDA Medical Device Recalls (openFDA)
AGFA Corp.: CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
- Recall number
- Z-0970-2013
- Recalling firm
- AGFA Corp.
- Product
- CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
- Status
- Terminated
- Initiated
- 2013-02-07
- Posted
- 2013-03-19
- Terminated
- 2013-06-06
- Reason
- The cassettes were shipped with the wrong IP (image plate) size bar code.
- Root cause
- Nonconforming Material/Component
- Action
- On February 7, 2013, AGFA called dealers involved to alert them of the safety issue. Also, an 'URGENT FIELD SAFETY NOTICE" letter dated February 26, 2013 was sent to the customers. The letter described the affected product, problem and actions to be taken. Customers were requested to check their inventories for the affected product and block any identified product within their inventory. Customers were instructed to complete the attached Feedback form and return via FAX or email. For questions call 877-777-2432 Prompt 5.
- Quantity
- 17
- Distribution
- USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
- Lot, serial or model codes
- Batch No. A2KQMW
- 510(k) numbers
- ["K121948"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- 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