Reported Nov 10, 2021 · Ongoing
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FujiFilm Healthcare Americas Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FujiFilm Healthcare Americas Corporation · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- Arietta 750 Ultrasound Software VersionV1.0.0 through V2.1.3
- Lot codes and dates
15 of 15 products
Products covered by this recall # Barcodes Product as published 1 04562122959841G3075073 (01)04562122959841(11)201214(21)G3075073 2 04562122959841G3110777 (01)04562122959841(11)210421(21)G3110777 3 04562122959841G3110771 (01)04562122959841(11)210421(21)G3110771 4 04562122959841G3113780 (01)04562122959841(11)210510(21)G3113780 5 04562122959841G3113778 (01)04562122959841(11)210510(21)G3113778 6 04562122959841G3113779 (01)04562122959841(11)210510(21)G3113779 7 04562122959841G3113777 (01)04562122959841(11)210510(21)G3113777 8 04562122959841G3071857 (01)04562122959841(11)210420(21)G3071857 9 04562122959841G3108384 (01)04562122959841(11)210402(21)G3108384 10 04562122959841G3114220 (01)04562122959841(11)210510(21)G3114220 11 04562122959841G3110776 (01)04562122959841(11)210421(21)G3110776 12 04562122959841G3108385 (01)04562122959841(11)210402(21)G3108385 13 04562122959841G3114223 (01)04562122959841(11)210518(21)G3114223 14 04562122959841G3108401 (01)04562122959841(11)210420(21)G3108401 15 04562122959841G3114959 (01)04562122959841(11)210524(21)G3114959 - Amount recalled
- 15 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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