GE Medical Systems, SCS: Medical Device Recall in 2024 - (Recall #: Z-0862-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Senographe Pristina

Product Classification:

Class II

Date Initiated: December 26, 2023

Date Posted: February 14, 2024

Recall Number: Z-0862-2024

Event ID: 93837

Reason for Recall:

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

Status: Ongoing

Product Quantity: 180 units (60 US; 120 OUS)

Code Information:

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

Distribution Pattern:

Us Nationwide-Worldwide Distribution

Voluntary or Mandated:

FDA Mandated