Fujifilm Medical Systems U.S.A., Inc. - FullField Digital Mammography Xray System - Class 2 Recall

ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=161292

Source: Medical Device Recalls - February 21, 2018 Category: Medical Devices Source Type: alerts