GE Healthcare, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
GE Healthcare, LLC is recalling GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images th due to Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
Recommended Action
Per FDA guidance
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,
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026