# FDA recall Z-1065-2018

> **Siemens Medical Solutions USA, Inc.** · Class II · device recall initiated 2018-01-26.

## Product

ACUSON SC2000 Ultrasound System    Product Usage:  The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

## Reason for recall

The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.

## Distribution

Worldwide Distribution - U.S. nationwide and the countries of  Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta, Mexico, Netherlands, Norway, Pakistan, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, U.A.E, Ukraine, United Kingdom, United States, Uzbekistan, and Vietnam.

## Key facts

- **Recall number:** Z-1065-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-26
- **Report date:** 2018-03-21
- **Termination date:** 2020-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mountain View, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1065-2018

## Citation

> AI Analytics. FDA recall Z-1065-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1065-2018. Source: US FDA. Licensed CC0.

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