Recall Z-0970-2013 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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.
| Date | Mar 19, 2013 (initiated Feb 7, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121948 | CR 10-X DIGITIZER Agfa Healthcare N.V., Jul 20, 2012 |