Company:AGFA Corp.,
Date of Enforcement Report:11/29/2006
Class:ll
PRODUCT
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007
REASON
Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
CODE
60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by service bulletin on September 1, 2006 and by telephone and email on October 13, 2006.
Manufacturer: AGFC Corp., Mortsel, Belgium. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide
