FDA-Device2013-03-27Class II
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.
AGFA Corp.
Hazard
The cassettes were shipped with the wrong IP (image plate) size bar code.
Sold states
USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
Affected count
17
Manufactured in
10 S Academy St, N/A, Greenville, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0970-2013Don't want to check this manually?
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