Hitachi Medical Systems America Inc: Medical Device Recall in 2021 - (Recall #: Z-1282-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 1, 2021

Date Posted: March 31, 2021

Recall Number: Z-1282-2021

Event ID: 87493

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1

Code Information:

Asset Tag: U8AR0479 Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2

Distribution Pattern:

US Nationwide distribution in the state of TX.

Voluntary or Mandated:

Voluntary: Firm initiated