FUJIFILM Healthcare Americas Corporation: ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P16

Hazard

Devices had an unapproved slabbing software function enabled for use.

Details from the source

Reason for recall: Devices had an unapproved slabbing software function enabled for use. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador. Quantity: 293 units Lot/code info: Model No. CLLE-0229; UDI: (01)01547410297546(11)210701(21)16724035, (01)045474100297546(11)191001(21)967022860, (01)045474100297546(11)191001(21)97022857, (01)045474100297546(11)191001(21)97022858, (01)045474100297546(11)191001(21)97022861, (01)04547410294546(11)190801(21)96822763, (01)04547410294546(11)190801(21)96822764, (01)04547410294546(11)190801(21)96822765, (01)04547410294546(11)190801(21)96822767, (01)04547410294576(11)210501(21)16523949, (01)04547410294576(11)210501(21)16523950, (01)04547410294576(11)210601(21)16623962, (01)04547410294576(11)210601(21)16623963, (01)04547410297546(01)170601(21)76621287, (01)04547410297546(11)000100(21)67121008, (01)04547410297546(11)160107(21)66120675, (01)04547410297546(11)170201(21)76221098, (01)04547410297546(11)170220(21)67121004, (01)04547410297546(11)170301(21)76321131, (01)04547410297546(11)170301(21)76321132, (01)04547410297546(11)170301(21)76321136, (01)04547410297546(11)170501(21)76521235, (01)04547410297546(11)170501(21)76521236, (01)04547410297546(11)170501(21)76521237, (01)04547410297546(11)170501(21)76521238, (01)04547410297546(11)170720(21)76621277, (01)04547410297546(11)170731(21)76621278, (01)04547410297546(11)170801(21)76821374, (01)04547410297546(11)170801(21)76821375, (01)04547410297546(11)170923(21)76121056, (01)04547410297546(11)171001(21)77021484, (01)04547410297546(11)171001(21)77021485, (01)04547410297546(11)171001(21)77021486, (01)04547410297546(11)171006(21)76821376, (01)04547410297546(11)171101(77)121559, (

UPC codes

01547410297546, 04547410294546, 04547410294576, 04547410297546, 04574102975456, 17070176721324, 17070176721325

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.