CLASS II ONGOING Device recall · Reported 10 Nov 2021 · FDA Enforcement Report
Lisendo 880 Ultrasound recalled by FujiFilm Healthcare Americas
FujiFilm Healthcare Americas is recalling Lisendo 880 Ultrasound, distributed nationwide in the US. The recall was initiated on 14 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0191-2022
- FDA event ID
- 88840
- Recalling firm
- FujiFilm Healthcare Americas, Twinsburg, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Oct 2021
- FDA classified
- 2 Nov 2021
- Reported
- 10 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 14 Oct 2021 | Recall initiated by company | |
| 2 Nov 2021 | Classified by FDA | +19 days |
| 10 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 88840This product is part of a recall event; the main page for the event is Arietta 850 Ultrasound recalled by FujiFilm Healthcare Americas.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Arietta 850 Ultrasound recalled by FujiFilm Healthcare Americas | FujiFilm Healthcare Americas | Device Malfunction | Nationwide | |
| CLASS II | Arietta 750 Ultrasound recalled by FujiFilm Healthcare Americas | FujiFilm Healthcare Americas | Device Malfunction | Nationwide |
More recalls from FujiFilm Healthcare Americas
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Labeling Errors | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Other | Nationwide |
| Device | CLASS II | FDR Visionary Suite recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 8 states |
| Device | CLASS II | Asprire Cristalle Mammography System recalled | Fujifilm Healthcare Americas | Device Malfunction | Nationwide |
| Device | CLASS II | Synapse PACS recalled by FUJIFILM Healthcare Americas | Fujifilm Healthcare Americas | Device Malfunction | 30 states |
Other Imaging Equipment recalls
All 2,336| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device recalled | Canon Medical System USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |