Device 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.
Z-0970-2013
Product summary
- Firm
- AGFA Corp.
- Event
- Event 64529
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17
- Official record key
device-enforcement:Z-0970-2013
Official wording
Reason: The cassettes were shipped with the wrong IP (image plate) size bar code.
Code information: Batch No. A2KQMW
Distribution pattern: USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
Derived failure modes
-
Unknown
The cassettes were shipped with the wrong IP (image plate) size bar code.