# FDA recall Z-2131-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-05-16.

## Product

GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.

## Reason for recall

Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.

## Distribution

Worldwide distribution - US nationwide distribution in the states of AZ, CA, FL, GA, IL, MI, MN, NC, NJ, NY, PA, TX, and VT, and countries of Algeria, Australia, Belgium, Canada, Chile, Columbia, Czech Republic, Finland, France, Germany, Hungary, Iceland, Japan, Korea (Republic of), Kuwait, Lebanon, New Zealand, Norway, Poland, Saudi Arabia, Senegal, South Africa, Sri Lanka, Sweden, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-2131-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-16
- **Report date:** 2019-08-07
- **Termination date:** 2020-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2019

## Citation

> AI Analytics. FDA recall Z-2131-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2131-2019. Source: US FDA. Licensed CC0.

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