FDA Medical Device Recalls (openFDA)
GE Medical Systems, SCS: Senographe Pristina
- Recall number
- Z-0862-2024
- Recalling firm
- GE Medical Systems, SCS
- Product
- Senographe Pristina
- Status
- Open, Classified
- Initiated
- 2023-12-26
- Posted
- 2024-02-08
- Terminated
- not on file
- Reason
- X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- GE HealthCare will, without charge, remedy the defect or bring the product into compliance. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 180 units (60 US; 120 OUS)
- Distribution
- Us Nationwide-Worldwide Distribution
- Lot, serial or model codes
- GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
- 510(k) numbers
- ["K162268","K173576","K182951","K193334","K211215"]
- PMA numbers
- not on file
- Product code
- MUE
- Firm FEI
- 1000284313
- Firm city
- Buc
- Firm state
- not on file
- Firm country
- France
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