medical Class II Updated 2024-02-14

GE Medical Systems, SCS recalls Senographe Pristina

Recalled Product

Senographe Pristina

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
View official government recall

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