Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning GE MEDICAL SYSTEMS SCS Senographe Pristina [GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879] [HKMD numbers: 180193].
According to the FDA, the manufacturer has identified that X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93837
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 Feb 2024