AGFA Corp.: Medical Device Recall in 2013 - (Recall #: Z-0970-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 7, 2013

Date Posted: March 27, 2013

Recall Number: Z-0970-2013

Event ID: 64529

Reason for Recall:

The cassettes were shipped with the wrong IP (image plate) size bar code.

Status: Terminated

Product Quantity: 17

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.

Voluntary or Mandated:

Voluntary: Firm initiated