FDA Medical Device Recalls (openFDA)
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 number
- Z-2131-2019
- Recalling firm
- GE Healthcare, LLC
- 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.
- Status
- Terminated
- Initiated
- 2019-05-16
- Posted
- not on file
- Terminated
- 2020-12-16
- Reason
- Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure.
- Root cause
- Equipment maintenance
- Action
- 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,
- Quantity
- 82
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K162268"]
- PMA numbers
- not on file
- Product code
- MUE
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28