GE Healthcare (China) Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
24
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1240-2025Class IIBrivo MR355, NMRI systemJanuary 31, 2025
Z-1242-2025Class IISIGNA MR355, SIGNA MR360, NMRI systemJanuary 31, 2025
Z-1239-2025Class IISIGNA Creator, SIGNA Explorer, NMRI systemsJanuary 31, 2025
Z-1243-2025Class IISIGNA MR380, NMRI system, Non-US OnlyJanuary 31, 2025
Z-1241-2025Class IIOptima MR360, NMRI systemJanuary 31, 2025
Z-0603-2025Class IIGE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systemsNovember 5, 2024
Z-0615-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: RevoluNovember 5, 2024
Z-0604-2025Class IIGE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systemsNovember 5, 2024
Z-0613-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh PacNovember 5, 2024
Z-0610-2025Class IIGE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, November 5, 2024
Z-0606-2025Class IIGE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography systemNovember 5, 2024
Z-0605-2025Class IIGE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography systemNovember 5, 2024
Z-0607-2025Class IIGE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography systemNovember 5, 2024
Z-0609-2025Class IIGE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomogNovember 5, 2024
Z-0611-2025Class IIGE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography systemNovember 5, 2024
Z-0616-2025Class IIGE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: DiscovNovember 5, 2024
Z-0608-2025Class IIGE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography systemNovember 5, 2024
Z-0601-2025Class IIGE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systemsNovember 5, 2024
Z-0600-2025Class IIGE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:November 5, 2024
Z-0602-2025Class IIGE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography systemNovember 5, 2024