FDA recall Z-2132-2019

Product

GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2132-2019