# FDA recall Z-1010-2022

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2022-03-07.

## Product

Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,

## Reason for recall

Transducers (component of ultrasound system) may exceed recommended thermal index limits

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, Texas and the countries of Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, New Zealand.

## Key facts

- **Recall number:** Z-1010-2022
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-07
- **Report date:** 2022-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Issaquah, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2022

## Citation

> AI Analytics. FDA recall Z-1010-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1010-2022. Source: US FDA. Licensed CC0.

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