Recall Z-0464-2011 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
AGFA Corp.
DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
| Date | Nov 26, 2010 (initiated Oct 8, 2010) |
| Status | Terminated |
| Reason | Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee. |
| Root cause | Other |
| Action | Agfa halted Installation of the incorrect unit, and the unit was sent to Agfa warehouse in Carlstadt, NJ, where it is being held in quarantine for export. |
| Quantity | One unit |
| Distribution | Nationside Distribution: to NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS Agfa Healthcare N.V., Aug 11, 2009 |