# FDA recall Z-1341-2020

> **Hitachi Medical Systems America Inc** · Class II · device recall initiated 2020-01-31.

## Product

UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.

## Reason for recall

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

## Distribution

Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-1341-2020
- **Recalling firm:** Hitachi Medical Systems America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-31
- **Report date:** 2020-02-26
- **Termination date:** 2020-07-31

- **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-1341-2020

## Citation

> AI Analytics. FDA recall Z-1341-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1341-2020. Source: US FDA. Licensed CC0.

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