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.
Reported: August 7, 2019 Initiated: May 16, 2019 #Z-2131-2019
Product Description
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 82
- 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.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by GE Healthcare, LLC. Units affected: 82.
Why was this product recalled? ▼
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2019. Severity: Moderate. Recall number: Z-2131-2019.
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