ClearanceBrief
Recall Z-1404-05 ยท IXA Cassette, Radiographic Film

AGFA Corp.

Radiomat Lightweight Cassettes

DateAug 25, 2005 (initiated Jan 26, 2005)
StatusTerminated
ReasonUsers of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
Root causeOther
ActionConsignees were notified by letter on/about 07/29/2005.
Quantity9055 units
DistributionNationwide, Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
Agfa Corp., Sep 26, 2002