—#174661

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.

FDA product code: MUE — Full Field Digital, System, X-Ray, Mammographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173576
Affected lot / code info: Serial# 738192BU4, 738574BU3, 734192BU8, 733706BU6, 718590BU3, 735558BU9, 738023BU1, 737211BU3, 739178BU2, 733600BU1, 738696BU4, 738793BU9, 738695BU6, 734169BU6, 733707BU4 and 732113BU6

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

On May 17, 2019, GE Healthcare sent letters to all of their consignees advising them of the recall, providing them with new instructions for use, and requesting that they complete the enclosed MEDICAL DEVICE NOTIFICATION ACKNOWLEDGEMENT RESPONSE REQUIRED forms. GE will follow-up and correct these systems,

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-05-16
Terminated: 2020-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174661. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.