Lisendo 880 Ultrasound Software Version: V1.0 through recall: Software Issue
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Why was Lisendo 880 Ultrasound Software Version: V1.0 through 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
- Recalling firm
- FujiFilm Healthcare Americas Corporation
- Quantity
- N/A
- Distribution
- Nationwide
- Recall date
- November 10, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)