The Recall Desk
HighFDA (Devices)·Z-0190-2022·Announced 2021-11-10

Arietta 850 Ultrasound Software Displays Cardiology Measurements Incorrectly

FujiFilm Arietta 850 ultrasound systems with affected software versions display cardiology measurement results incorrectly. The recall affects 38 units distributed nationwide.

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 recall without reported hospitalizations or adverse events. The defect affects measurement display in critical cardiology diagnostic functions where incorrect results could impact diagnosis accuracy, but no actual patient harm has been reported. This constitutes a risk-of-harm medical device where injury has not yet been reported.

Plain-English summary

FujiFilm Healthcare Americas Corporation is recalling Arietta 850 Ultrasound systems with software versions V1.0.0 through V4.1.3. The affected systems do not display measurement results correctly for two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement and Mitral Valve (MV) Measurement. The instruction manual also contains an error.

A total of 38 units are affected by this recall, distributed nationwide. These diagnostic ultrasound systems are used in conjunction with Fujifilm (formerly Hitachi) transducers for cardiac imaging. Healthcare facilities should identify whether their Arietta 850 systems are affected by comparing their device serial numbers and software versions against the FDA recall notice.

Facilities with affected devices should contact FujiFilm Healthcare Americas Corporation to obtain corrective software updates or replacement units. Because the affected measurement functions are critical for cardiac diagnosis, incorrect display of results could lead to misdiagnosis.

The recalled product

Product
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Manufacturer
FujiFilm Healthcare Americas Corporation
Category
Medical Device — Diagnostic Ultrasound
Hazard
  • measurement-display-error
  • instruction-manual-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 (20)

  • Serial Numbers: 205W3386 (01)04562122958974(11)171114(21)205W3386
  • 206F7900 (01)04562122958974(11)180926(21)206F7900
  • 206F7901 (01)04562122958974(11)180926(21)206F7901
  • 206F7936 (01)04562122958974(11)181113(21)206F7936
  • 206F7937 (01)04562122958974(11)181113(21)206F7937
  • 206F7940 (01)04562122958974(11)181113(21)206F7940
  • 206F7941 (01)04562122958974(11)181113(21)206F7941
  • 206F7942 (01)04562122958974(11)181113(21)206F7942
  • 206F7944 (01)04562122958974(11)181113(21)206F7944
  • 206F7945 (01)04562122958974(11)181113(21)206F7945
  • 206F7946 (01)04562122958974(11)181113(21)206F7946
  • 206F7947 (01)04562122958974(11)181114(21)206F7947
  • G3002552 (01)04562122958974(11)20190115(21)G3002552
  • G3024545 (01)04562122958974(11)190607(21)G3024545
  • G3037885 (01)04562122958974(11)20190719(21)G3037885
  • G3037887 (01)04562122958974(11)20190719(21)G3037887
  • G3042405 (01)04562122958974(11)190829(21)G3042405
  • G3042823 (01)04562122958974(11)20190807(21)G3042823
  • G3042828 (01)04562122958974(11)20190808(21)G3042828
  • G3045094 (01)04562122958974(11)20190822(21)G3045094

Distribution

Distributed nationwide across the United States.

Related recalls

Same category