Recall Z-2131-2019— GE Healthcare, LLC

Name: FDA recall Z-2131-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-05-16, terminated 2020-12-16. It names one FDA 510(k) clearance: K162268. 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: Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-05-16
Terminated: 2020-12-16
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K162268 — Senographe PristinaGE Healthcare·cleared 2016-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.