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.

Code information: Serial# 716784BU4, 716785BU1, 716786BU9, 716787BU7, 716788BU5, 718583BU8, 718584BU6, 718585BU3, 718586BU1, 718587BU9, 718588BU7, 718589BU5, 718591BU1, 718592BU9, 718593BU7, 718594BU5, 718595BU2, 718596BU0, 718597BU8, 718598BU6, 718599BU4 , 718600BU0, 718601BU8, 718602BU6, 722648BU3, 722649BU1, 722653BU3, 722654BU1, 722655BU8, 722656BU6, 722657BU4, 730124BU5, 730125BU2, 730126BU0, 730292BU0, 730293BU8, 730663BU2, 730664BU0, 730665BU7, 732049BU2, 732050BU0, 732303BU3, 732304BU1, 732305BU8, 732362BU9, 732363BU7, 732448BU6, 732449BU4, 732450BU2, 732727BU3, 732728BU1, 733031BU9, 733903BU9, 733904BU7, 734170BU4, 734206BU6, 734840BU2, 735432BU7, 735779BU1, 736006BU8, 736007BU6, 736008BU4, 736366BU6, 736588BU5, 738021BU5, 738356BU5, 738357BU3 , 738358BU1, 738557BU8, 738573BU5, 738586BU7, 738587BU5, 738712BU9, 738792BU1, 738794BU7, 738795BU4, 738864BU8, 739150BU1 and 739721BU9.

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.