Device product

Senographe Pristina

Z-0862-2024

December 26, 2023

Class II

Product summary

Firm: GE Medical Systems, SCS
Event: Event 93837
Status: Ongoing
Classification: Class II
Quantity: 180 units (60 US; 120 OUS)
Official record key: device-enforcement:Z-0862-2024

Official wording

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

Code information: GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879

Distribution pattern: Us Nationwide-Worldwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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