# FDA recall Z-1282-2021

> **Hitachi Medical Systems America Inc** · Class II · device recall initiated 2021-03-01.

## Product

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.

## 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.

## Distribution

US Nationwide distribution in the state of TX.

## Key facts

- **Recall number:** Z-1282-2021
- **Recalling firm:** Hitachi Medical Systems America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-01
- **Report date:** 2021-03-31
- **Termination date:** 2021-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Twinsburg, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1282-2021

## Citation

> AI Analytics. FDA recall Z-1282-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1282-2021. Source: US FDA. Licensed CC0.

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