Recall Z-1282-2021 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Hitachi Medical Systems America Inc
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Mu
| Date | Mar 1, 2021 |
| Status | Terminated |
| Reason | Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits. |
| Root cause | Software design |
| Action | On 3/1/2021, Hitachi issued an Urgent Medical Device Correction notice to customers for the Arietta 850 system operating with software version 4.0.2 that utilizes SWE function with the C252 probe. The R&D department of Hitachi Ltd. (Manufacturer) has identified an error in the focus point and transducer aperture settings in the SWE function at the manufacturer facility. This error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits. |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183456 | Aloka Arietta 850 Hitachi Healthcare Americas, Jan 28, 2019 |