The Recall Desk
HighFDA (Devices)·Z-0191-2022·Announced 2021-11-10

Lisendo 880 Ultrasound Software displays incorrect cardiac valve measurements

Lisendo 880 Ultrasound Software versions V1.0–V4.1.3 may not display cardiac measurement results correctly for mitral valve assessments, affecting diagnostic accuracy.

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 medical device with a measurement display error affecting diagnostic accuracy. No illnesses or injuries reported, but incorrect measurements present a potential risk of misdiagnosis, meeting the criterion for High severity in the rubric.

Plain-English summary

Lisendo 880 Ultrasound Software versions V1.0 through V4.1.3, used with Fujifilm transducers, does not display measurement results correctly for two cardiology functions: Mitral Regurgitation Flow (MR Flow) Measurement and Mitral Valve (MV) Measurement. This measurement display error affects the reliability of cardiac assessments performed with this software.

The software has been distributed nationwide in diagnostic ultrasound systems used in healthcare facilities. FujiFilm Healthcare Americas Corporation, the manufacturer, identified the measurement display defect and filed a Class II recall. The instruction manual also contains an error related to this issue.

Affected facilities using versions V1.0 through V4.1.3 should contact FujiFilm Healthcare Americas Corporation regarding corrective action or software updates to ensure accurate cardiac measurements.

The recalled product

Product
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Manufacturer
FujiFilm Healthcare Americas Corporation
Category
Medical Device — Ultrasound / Cardiac Imaging
Hazard
  • measurement-error
  • misdiagnosis-risk

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/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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category