GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

FDA Regulatory Profile

Summary

Total Recalls
41 (6 Class I)
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1112-2026Class IIGE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI LDecember 24, 2025
Z-1047-2026Class IIMAXXUS, System, Tomography, Computed, EmissionDecember 10, 2025
Z-1046-2026Class IISMV BodyTrack, System, Tomography, Computed, EmissionDecember 10, 2025
Z-1044-2026Class IISMV DSX New Line, System, Tomography, Computed, EmissionDecember 10, 2025
Z-1045-2026Class IISMV DSI, System, Tomography, Computed, EmissionDecember 10, 2025
Z-0292-2026Class IIElscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0300-2026Class IIMillenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0291-2026Class IIElscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0293-2026Class IIElscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0294-2026Class IIElscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0303-2026Class IIStarcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0302-2026Class IISopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera desiSeptember 12, 2025
Z-0299-2026Class IIMillenium MPR; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0298-2026Class IIMillenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaginSeptember 12, 2025
Z-0301-2026Class IIOptima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0290-2026Class IIElscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0297-2026Class IIMillenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0296-2026Class IIMaxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-0295-2026Class IIElscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imagingSeptember 12, 2025
Z-2098-2025Class IIVaricam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine SystemJune 20, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K243605AuroraJanuary 17, 2025
K241350Clarify DLJanuary 3, 2025
K241665Omni LegendAugust 8, 2024
K102231DISCOVERY NM 750BNovember 3, 2010