Home / Recalls / GE Medical Systems, SCS / Z-0862-2024

Z-0862-2024 Class II Ongoing

Recalled by GE Medical Systems, SCS — Buc

Recall Details

Product Type
Devices
Report Date
February 14, 2024
Initiation Date
December 26, 2023
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
180 units (60 US; 120 OUS)

Product Description

Senographe Pristina

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.

Distribution Pattern

Us Nationwide-Worldwide Distribution

Code Information

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

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  • Z-1778-2024 Class II — GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems (March 18, 2024)
  • Z-1783-2024 Class II — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems (March 18, 2024)
  • Z-1780-2024 Class II — GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems (March 18, 2024)
  • Z-1779-2024 Class II — GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems (March 18, 2024)
  • Z-1782-2024 Class II — GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems (March 18, 2024)
  • Z-1777-2024 Class II — GE Healthcare Innova IGS 5, computed tomography x-ray system (March 18, 2024)
  • Z-2388-2018 Class II — Discovery IGS 740 Interventional Fluoroscopic X-ray Systems (March 29, 2018)
  • Z-2386-2018 Class II — Discovery IGS 730 Interventional Fluoroscopic X-ray Systems (March 29, 2018)