ClearanceBrief
Recall Z-0939-04 ยท ITY Assembly, Tube Housing, X-Ray, Diagnostic

Fischer Imaging Corporation

SenoScan True View Digital Mammography System

DateJul 20, 2004 (initiated Apr 12, 2004)
StatusTerminated
ReasonX-ray tube may overheat after high usage because of mis-wired thermal switch circuit.
Root causeOther
ActionCustomers were notified by certified mail on 4/19/2004.
Quantity37
DistributionNationwide CA, CO, FL, IN, MA, MO, NC, NY, OK, TX, WI, Mexico, France. No government or military distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.