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GE Medical Systems, SCS Recall 93837

Description: Senographe Pristina

GE Medical Systems, SCS Recall 93837 Information

Mandated?FDA Mandated
Recall NumberZ-0862-2024
Event ID93837
Event DescriptionSenographe Pristina
Product TypeDevices
DistributionUs Nationwide-Worldwide Distribution
Quantity180 units (60 US; 120 OUS)
Recall ReasonX-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Device Classification20240214
Device Code InfoGTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
Center Classification Date20240208
Recall Initiation Date20231226
Recalling FirmGE Medical Systems, SCS
Initial Notification Letter
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