FujiFilm Healthcare Americas Corporation Recall 88840
Description: Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FujiFilm Healthcare Americas Corporation Recall 88840 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0190-2022 |
| Event ID | 88840 |
| Event Description | Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 |
| Product Type | Devices |
| Distribution | Nationwide |
| Quantity | 38 units |
| Recall Reason | 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 Classification | 20211110 |
| Device Code Info | 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 |
| Center Classification Date | 20211102 |
| Recall Initiation Date | 20211014 |
| Recalling Firm | FujiFilm Healthcare Americas Corporation |
| Initial Notification | Letter |
| Similar To |