The Recall Desk
HighFDA (Devices)·Z-0189-2022·Announced 2021-11-10

Arietta 750 Ultrasound Software Versions Affected by Incorrect Measurement Display

FujiFilm Healthcare is recalling Arietta 750 Ultrasound Software versions V1.0.0 through V2.1.3 due to measurement display errors in critical cardiology functions that could lead to incorrect clinical diagnoses. The instruction manual also contains an error.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall. The software defect creates a risk of harm by providing incorrect diagnostic measurements in critical cardiology functions, but no injuries or illnesses have been reported. This meets the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

FujiFilm Healthcare Americas Corporation is recalling certain versions (V1.0.0 through V2.1.3) of Arietta 750 Ultrasound Software used with Fujifilm transducers. The software has a defect that prevents it from correctly displaying measurement results for two critical cardiology functions: Mitral Regurgitation Flow (MR Flow) Measurement and Mitral Valve (MV) Measurement. Additionally, the instruction manual contains an error.

Affected systems are located nationwide, with 15 units identified. The software's measurement display error could result in clinicians receiving inaccurate diagnostic data, potentially affecting clinical decisions regarding cardiac assessment.

Healthcare facilities currently using affected Arietta 750 Ultrasound systems should contact FujiFilm Healthcare Americas Corporation for guidance. Users should not rely on the affected cardiology measurement functions until a corrected software version is provided.

The recalled product

Product
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Manufacturer
FujiFilm Healthcare Americas Corporation
Category
Medical Device — Diagnostic Ultrasound System
Hazard
  • measurement-error
  • documentation-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category