FDA-Device2024-02-14Class II
Senographe Pristina
GE Medical Systems, SCS
Hazard
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Sold states
Us Nationwide-Worldwide Distribution
Affected count
180 units (60 US; 120 OUS)
Manufactured in
283 rue de la Miniere, Buc, France
Products
Senographe Pristina
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0862-2024Don't want to check this manually?
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