FDA Device

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

Hazard

Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.

What You Should Do

Remedy

Consignees were notified by letter on/about 06/28/2006.

Products

CR DX-S, Image Intensified Fluoroscopic X-ray system.
Brand
AGFA Corp.
UPC
Units with Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.

Units Affected

11 units