Senographe Pristina
This recall is currently active, issued February 8, 2024. It was issued by Ge Medical Systems, Scs.
- Company
- Ge Medical Systems, Scs
- Recall Initiated
- December 26, 2023
- Posted
- February 8, 2024
- Recall Number
- Z-0862-2024
- Quantity
- 180 units (60 US; 120 OUS)
- Official Source
- View on FDA website ↗
Reason for Recall
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Distribution
Us Nationwide-Worldwide Distribution
Lot / Code Info
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.