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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88840

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 14, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
FujiFilm Healthcare Americas Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

Z-0189-2022
Recall number
Z-0189-2022
Initiated
October 14, 2021
Classification
Class II
Status
Ongoing
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

Nationwide

device · product 2 of 3

Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3

Z-0190-2022
Recall number
Z-0190-2022
Initiated
October 14, 2021
Classification
Class II
Status
Ongoing
Quantity
38 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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; G3052105 (01)04562122958974(11)20191008(21)G3052105 G3052118 (01)04562122958974(11)20191025(21)G3052118 G3055549 (01)04562122958974(11)20191118(21)G3055549 G3055550 (01)04562122958974(11)20191118(21)G3055550 G3055552 (01)04562122958974(11)20191118(21)G3055552 G3055553 (01)04562122958974(11)20191118(21)G3055553 G3055554 (01)04562122958974(11)20191118(21)G3055554 G3055555 (01)04562122958974(11)20191118(21)G3055555 G3060234 (01)04562122958974(11)20191206(21)G3060234 G3060254 (01)04562122958974(11)20191206(21)G3060254 G3060275 (01)04562122958974(11)20191216(21)G3060275 G3060278 (01)04562122958974(11)20191216(21)G3060278 G3060690 (01)04562122958974(11)200127(21)G3060690 G3071074 (01)04562122958974(11)20200227(21)G3071074 G3080785 (01)04562122958974(11)201105(21)G3080785 G3090450 (01)04562122958974(11)201225(21)G3090450 G3110884 (01)04562122958974(11)210401(21)G3110884

Distribution pattern

Nationwide

device · product 3 of 3

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3

Z-0191-2022
Recall number
Z-0191-2022
Initiated
October 14, 2021
Classification
Class II
Status
Ongoing
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Serial Numbers/UDI: 20514657 (01)04562122958868(11)161220(21)20514657; 20659147 (01)04562122958868(11)20181124(21)20659147; 20659148 (01)04562122958868(11)20181124(21)20659148; 20659149 (01)04562122958868(11)20181124(21)20659149; 20659150 (01)04562122958868(11)20181124(21)20659150; 20659153 (01)04562122958868(11)20181126(21)20659153; 20659154 (01)04562122958868(11)20181126(21)20659154; 20659155 (01)04562122958868(11)20181126(21)20659155; 20659156 (01)04562122958868(11)20181126(21)20659156; 205G0225 (01)04562122958868(11)20170418(21)205G0225; 205G0226 (01)04562122958868(11)20170424(21)205G0226; 205P2146 (01)04562122958868(11)20170615(21)205P2146; 205P2147 (01)04562122958868(11)20170615(21)205P2147; 205P2148 (01)04562122958868(11)20170615(21)205P2148; 205P2149 (01)04562122958868(11)20170615(21)205P2149; 205Q0809 (01)04562122958868(11)20170707(21)205Q0809; 205Q0810 (01)04562122958868(11)20170707(21)205Q0810; 205Q0812 (01)04562122958868(11)20170707(21)205Q0812; 205Q0815 (01)04562122958868(11)20171006(21)205Q0815; 205T7139 (01)04562122958868(11)20171006(21)205T7139; 205T7143 (01)04562122958868(11)20171026(21)205T7143; 205V5544 (01)04562122958868(11)20171026(21)205V5544; 205V5545 (01)04562122958868(11)20171030(21)205V5545; 205V5547 (01)04562122958868(11)20171031(21)205V5547; 205V5548 (01)04562122958868(11)20171031(21)205V5548; G3005239 (01)04562122958868(11)20190308(21)G3005239; G3005240 (01)04562122958868(11)20190308(21)G3005240; G3025041 (01)04562122958868(11)20190603(21)G3025041; G3025042 (01)04562122958868(11)20190604(21)G3025042; G3025044 (01)04562122958868(11)20190605(21)G3025044; G3025045 (01)04562122958868(11)20190605(21)G3025045; G3025048 (01)04562122958868(11)20190606(21)G3025048; G3025049 (01)04562122958868(11)20190606(21)G3025049; G3037183 (01)04562122958868(11)20190624(21)G3037183; G3037184 (01)04562122958868(11)20190624(21)G3037184; G3037192 (01)04562122958868(11)20190709(21)G3037192; G3043580 (01)04562122958868(11)20190820(21)G3043580; G3043581 (01)04562122958868(11)20190820(21)G3043581; G3043582 (01)04562122958868(11)20190820(21)G3043582; G3052217 (01)04562122958868(11)20191016(21)G3052217; G3052218 (01)04562122958868(11)20191016(21)G3052218; G3052225 (01)04562122958868(11)20191202(21)G3052225; G3052234 (01)04562122958868(11)20200128(21)G3052234; G3052236 (01)04562122958868(11)20200109(21)G3052236; G3054831 (01)04562122958868(11)20200115(21)G3054831; G3054833 (01)04562122958868(11)20191212(21)G3054833; G3054840 (01)04562122958868(11)20200115(21)G3054840; G3080616 (01)04562122958868(11)20201215(21)G3080616; G3080617 (01)04562122958868(11)20201215(21)G3080617; G3106256 (01)04562122958868(11)20210413(21)G3106256; G3106258 (01)04562122958868(11)20210413(21)G3106258; G3111572 (01)04562122958868(11)20210413(21)G3111572; G3111573 (01)04562122958868(11)20210421(21)G3111573

Distribution pattern

Nationwide