GE Medical Systems, SCS

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Known Names

ge medical systems, scs, ge medical systems scs

Recent Recalls

NumberClassProductDate
Z-0068-2026Class IIAW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2September 5, 2025
Z-1781-2024Class IIGE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systemsMarch 18, 2024
Z-1778-2024Class IIGE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systemsMarch 18, 2024
Z-1783-2024Class IIGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systemsMarch 18, 2024
Z-1780-2024Class IIGE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systemsMarch 18, 2024
Z-1777-2024Class IIGE Healthcare Innova IGS 5, computed tomography x-ray systemMarch 18, 2024
Z-1779-2024Class IIGE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systemsMarch 18, 2024
Z-1782-2024Class IIGE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systemsMarch 18, 2024
Z-0862-2024Class IISenographe PristinaDecember 26, 2023
Z-2387-2018Class IIInnova IGS 630/520/530/540 Interventional Fluoroscopic X-ray SystemsMarch 29, 2018
Z-2388-2018Class IIDiscovery IGS 740 Interventional Fluoroscopic X-ray SystemsMarch 29, 2018
Z-2386-2018Class IIDiscovery IGS 730 Interventional Fluoroscopic X-ray SystemsMarch 29, 2018