ClearanceBrief
Recall Z-0788-06 ยท IWZ Film, Radiographic

AGFA Corp.

Mamoray HDR-C PLUS Mammography film

DateApr 22, 2006 (initiated Feb 16, 2006)
StatusTerminated
ReasonThe film was incorrectly notched.
Root causeOther
ActionConsignees were notified by letter on/about 02/16/2006.
Quantity16523 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.