FDADecember 26, 2023device

Senographe Pristina

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems scs

UPCs

195278022745195278276971195278628916195278661999195278665379840682118460840682142052840682145879

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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