ClearanceBrief
Recall Z-0661-2018 ยท MUE Full Field Digital, System, X-Ray, Mammographic

Fujifilm Medical Systems U.S.A., Inc.

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.

DateAug 4, 2017
StatusTerminated
ReasonFUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may o
Root causeSoftware design
ActionThe firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction a
Quantity71 units (68 units Domestic. 3 units Foreign) in total
DistributionWorldwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K133972ASPIRE CRISTALLE
Fujifilm Medical Systems U.S.A, Inc., Mar 25, 2014