ClearanceBrief
Recall Z-0031-2007 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

AGFA Corp.

CR DX-S, Image Intensified Fluoroscopic X-ray system.

DateOct 12, 2006 (initiated Jun 28, 2006)
StatusTerminated
ReasonThree separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
Root causeOther
ActionConsignees were notified by letter on/about 06/28/2006.
Quantity11 units
DistributionCA, DC, FL, MN, MI, MS, OR.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K050810AGFA CR50.0
Agfa Corp., Apr 21, 2005