Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Check against the official notice below — it lists the full affected range.
FujiFilm Healthcare Americas Corporation recalled 15 units of its Arietta 750 Ultrasound System with software versions V1.0.0 through V2.1.3 that were distributed nationwide. The systems do not display measurement results correctly when used with a Fujifilm transducer for two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement and Mitral Valve (MV) Measurement. Additionally, there is an error in the instruction manual.
The affected units can be identified by specific serial numbers listed in the recall notice. The source does not specify a remedy or recommended action for consumers who own or operate affected systems.
Written by software from the official notice below. Not reviewed by a lawyer.
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual.
Reason for recall: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mitral Valve (MV) Measurement. In addition there is an error in the instruction manual. Distribution: Nationwide Quantity: 15 units Lot/code info: Serial Numbers: G3075073 (01)04562122959841(11)201214(21)G3075073; G3110777 (01)04562122959841(11)210421(21)G3110777; G3110771 (01)04562122959841(11)210421(21)G3110771; G3113780 (01)04562122959841(11)210510(21)G3113780; G3113778 (01)04562122959841(11)210510(21)G3113778; G3113779 (01)04562122959841(11)210510(21)G3113779; G3113777 (01)04562122959841(11)210510(21)G3113777; G3071857 (01)04562122959841(11)210420(21)G3071857; G3108384 (01)04562122959841(11)210402(21)G3108384; G3114220 (01)04562122959841(11)210510(21)G3114220; G3110776 (01)04562122959841(11)210421(21)G3110776; G3108385 (01)04562122959841(11)210402(21)G3108385; G3114223 (01)04562122959841(11)210518(21)G3114223; G3108401 (01)04562122959841(11)210420(21)G3108401; G3114959 (01)04562122959841(11)210524(21)G3114959
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.