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

Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results cor…

Recall #: Z-0191-2022
Affected scope: N/A
Initiated: October 14, 2021

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

FujiFilm Healthcare Americas Corporation recalled Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 - a moderate-severity action.

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 was recalled by FujiFilm Healthcare Americas Corporation in November 10, 2021. Reason: Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (for…. Check the official notice for the remedy. Verify recall #Z-0191-2022 with the FDA Devices before acting.

The recall

FujiFilm Healthcare Americas Corporation issued this moderate-severity FDA Devices recall-Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (for….

Moderate
severity level: Class II
classification: November 10, 2021
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0191-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0191-2022
Date reported	November 10, 2021
Date initiated	October 14, 2021
Recalling firm	FujiFilm Healthcare Americas Corporation
Firm location	Twinsburg, OH
Affected scope	N/A
Distribution	Nationwide

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0191-2022) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3. Recalled by FujiFilm Healthcare Americas Corporation. Units affected: N/A.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 10, 2021. Severity: Moderate. Recall number: Z-0191-2022.

Where was the recalled product distributed? ▼

Distribution: Nationwide.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

ABUS Recalls Youth Helmets Due to Risk of… 2021-11-10 Hart Consumer Products Recalls Nailers Du… 2021-11-10 Dr. Reddy's Ezetimibe and Simvastatin Tab… 2021-11-10 Dr. Reddy's Ezetimibe and Simvastatin Tab… 2021-11-10

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Monoject 0.9% Sodium Chloride, Flush Pref… 2021-11-10 FIVE S 3.5x65, Flexible Intubation Videos… 2021-11-10 Flexor Check-Flo Introducer, Introducer S… 2021-11-10 Flexor Check-Flo Introducer - Raabe Modif… 2021-11-10

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported November 10, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026