GE Medical Systems, SCS Senographe Pristina Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Senographe Pristina
Brand
GE Medical Systems, SCS
Lot Codes / Batch Numbers
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Products Sold
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
GE Medical Systems, SCS is recalling Senographe Pristina due to X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Recommended Action
Per FDA guidance
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.
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