Company:AGFA Corp.,
Date of Enforcement Report:10/18/2006
Class:ll
PRODUCT
CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007
REASON
Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
CODE
Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 28, 2006.
Manufacturer: AGFA Corp., Mortsel, Belgium. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide
