Hitachi Medical Systems America Inc recalls Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, e…

Recall date

March 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1282-2021

FDA classification

Class II

Brand / firm

Hitachi Medical Systems America Inc

Sold / distributed

US Nationwide distribution in the state of TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.