GE OEC Medical Systems, Inc

FDA Regulatory Profile

Summary

Total Recalls
48 (6 Class I)
510(k) Clearances
18
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0706-2025Class IIOEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designeNovember 21, 2024
Z-0704-2025Class IIOEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm isNovember 21, 2024
Z-0703-2025Class IIOEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscoNovember 21, 2024
Z-0705-2025Class IIOEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoNovember 21, 2024
Z-2277-2023Class IIOEC 9900 Systems with 9-inch Image IntensifierMay 15, 2023
Z-2276-2023Class IIOEC 9800 Systems with 9-inch Image IntensifierMay 15, 2023
Z-2279-2023Class IIField Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTENSIFIER, 9May 15, 2023
Z-2275-2023Class IIOEC Flexiview 8800 Systems with 9-inch Image IntensifierMay 15, 2023
Z-2278-2023Class IIOEC Elite Systems with 9-inch Image IntensifierMay 15, 2023
Z-2160-2021Class IIOEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to proJune 10, 2021
Z-2161-2021Class IIOEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of June 10, 2021
Z-1469-2017Class IIOEC FlexiView 8800, Digital Mobile Imaging System, GE Medical SystemsFebruary 21, 2017
Z-1059-2017Class IIOEC 9800. MDL Numbers: D222250, D141598December 27, 2016
Z-1060-2017Class IIOEC 9900 Elite. MDL Numbers: D148942, D155043December 27, 2016
Z-0975-2017Class IIThe OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film imageDecember 19, 2016
Z-0974-2017Class IIOEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to prDecember 19, 2016
Z-0973-2017Class IIOEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-fDecember 19, 2016
Z-0071-2017Class IIOEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC BrivoSeptember 23, 2016
Z-2628-2016Class IIOEC UroView 2800, fluoroscopic x-ray systemJuly 22, 2016
Z-2629-2016Class IIOEC 9800, fluoroscopic x-ray systemJuly 22, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K233669OEC 3DMarch 28, 2024
K203346OEC 3DMarch 5, 2021
K192819OEC EliteNovember 8, 2019
K172550OEC EliteNovember 16, 2017
K171565OEC EliteAugust 10, 2017
K132027OEC 9800 PLUSMay 1, 2014
K111551OEC(R) 9800, OEC(R) 9800 PLUSOctober 4, 2011
K073543OEC 9900 ELITEMay 2, 2008
K0619539900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONSAugust 15, 2006
K052039GE OEC ALTITUDEAugust 11, 2005
K051490GE OEC EVERVIEW 7500July 7, 2005
K043076GE OEC FLUOROSTARDecember 22, 2004
K041931OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATIONAugust 26, 2004
K041932OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEMAugust 18, 2004
K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMMarch 20, 2003
K022069OEC FLUOROTRAK 9800 PLUSSeptember 17, 2002
K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMApril 17, 2002
K003837FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEMMarch 12, 2001