FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Recall number
- Z-0875-2026
- Recalling firm
- GE Medical Systems, LLC
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Status
- Open, Classified
- Initiated
- 2025-10-24
- Posted
- 2025-12-09
- Terminated
- not on file
- Reason
- Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j).
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE Healthcare notified sent customers notification letter dated October 24, 2025 and instructed in the letter, the customer will inspect and identify systems that have a missing or incorrect label.
- Quantity
- 1,818 (1,580 US; 238 OUS)
- Distribution
- U.S. and OUS.
- Lot, serial or model codes
- GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
- 510(k) numbers
- ["K162268","K173576","K182951"]
- 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