# FDA recall Z-0816-2018

> **Hitachi Medical Systems America Inc** · Class II · device recall initiated 2017-10-20.

## Product

Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

## Reason for recall

The ultrasound probe may not have adequate protection against electrical shock hazards.

## Distribution

Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.

## Key facts

- **Recall number:** Z-0816-2018
- **Recalling firm:** Hitachi Medical Systems America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-20
- **Report date:** 2018-03-07
- **Termination date:** 2020-04-16

- **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-0816-2018

## Citation

> AI Analytics. FDA recall Z-0816-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0816-2018. Source: US FDA. Licensed CC0.

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