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GE OEC Medical Systems, Inc

89 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile flu recall (Z-0703-2025)GE OEC Medical Systems, Inc2024-12-18
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C- recall (Z-0704-2025)GE OEC Medical Systems, Inc2024-12-18
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobil recall (Z-0705-2025)GE OEC Medical Systems, Inc2024-12-18
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is d recall (Z-0706-2025)GE OEC Medical Systems, Inc2024-12-18
OEC Flexiview 8800 Systems with 9-inch Image Intensifier recall (Z-2275-2023)GE OEC Medical Systems, Inc2023-07-31
OEC 9800 Systems with 9-inch Image Intensifier recall (Z-2276-2023)GE OEC Medical Systems, Inc2023-07-31
OEC 9900 Systems with 9-inch Image Intensifier recall (Z-2277-2023)GE OEC Medical Systems, Inc2023-07-31
OEC Elite Systems with 9-inch Image Intensifier recall (Z-2278-2023)GE OEC Medical Systems, Inc2023-07-31
Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTE recall (Z-2279-2023)GE OEC Medical Systems, Inc2023-07-31
OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems recall (Z-1469-2017)GE OEC Medical Systems, Inc2017-02-27
OEC 9800. MDL Numbers: D222250, D141598 recall (Z-1059-2017)GE OEC Medical Systems, Inc2017-01-20
OEC 9900 Elite. MDL Numbers: D148942, D155043 recall (Z-1060-2017)GE OEC Medical Systems, Inc2017-01-20
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic a recall (Z-0973-2017)GE OEC Medical Systems, Inc2017-01-09
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is desig recall (Z-0974-2017)GE OEC Medical Systems, Inc2017-01-09
The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot- recall (Z-0975-2017)GE OEC Medical Systems, Inc2017-01-09
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC recall (Z-0071-2017)GE OEC Medical Systems, Inc2016-10-11
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW) recall (Z-1638-2015)GE OEC Medical Systems, Inc2015-06-08
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications a recall (Z-0840-2015)GE OEC Medical Systems, Inc2015-01-13
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications an recall (Z-0841-2015)GE OEC Medical Systems, Inc2015-01-13
OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imagi recall (Z-0192-2015)GE OEC Medical Systems, Inc2014-11-07
OEC MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician recall (Z-0193-2015)GE OEC Medical Systems, Inc2014-11-07
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging Sy recall (Z-0194-2015)GE OEC Medical Systems, Inc2014-11-07
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film ima recall (Z-0195-2015)GE OEC Medical Systems, Inc2014-11-07
The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is des recall (Z-1462-2014)GE OEC Medical Systems, Inc2014-04-16
InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation recall (Z-0524-2014)GE OEC Medical Systems, Inc2013-12-17
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (I recall (Z-2251-2012)GE OEC Medical Systems, Inc2012-08-28
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-r recall (Z-2262-2012)GE OEC Medical Systems, Inc2012-08-23
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to loca recall (Z-2236-2012)GE OEC Medical Systems, Inc2012-08-22
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fl recall (Z-2240-2012)GE OEC Medical Systems, Inc2012-08-22
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp f recall (Z-2241-2012)GE OEC Medical Systems, Inc2012-08-22
GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT recall (Z-2221-2012)GE OEC Medical Systems, Inc2012-08-17
Radiological Image Processing System The system is an aid to locate anatomical structures recall (Z-2136-2012)GE OEC Medical Systems, Inc2012-08-08
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluorosco recall (Z-2125-2012)GE OEC Medical Systems, Inc2012-08-01
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile recall (Z-2126-2012)GE OEC Medical Systems, Inc2012-08-01
UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot recall (Z-2127-2012)GE OEC Medical Systems, Inc2012-08-01
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892 recall (Z-2038-2012)GE OEC Medical Systems, Inc2012-07-24
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, sur recall (Z-2040-2012)GE OEC Medical Systems, Inc2012-07-24
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The recall (Z-2065-2012)GE OEC Medical Systems, Inc2012-07-24
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an ai recall (Z-2025-2012)GE OEC Medical Systems, Inc2012-07-18
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System desi recall (Z-2026-2012)GE OEC Medical Systems, Inc2012-07-18
OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient d recall (Z-2027-2012)GE OEC Medical Systems, Inc2012-07-18
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Mode recall (Z-1985-2012)GE OEC Medical Systems, Inc2012-07-12
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tappi recall (Z-1989-2012)GE OEC Medical Systems, Inc2012-07-11
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film ima recall (Z-1865-2012)GE OEC Medical Systems, Inc2012-06-22
Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surg recall (Z-1941-2011)GE OEC Medical Systems, Inc2011-04-11
Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcar recall (Z-1942-2011)GE OEC Medical Systems, Inc2011-04-11
GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Sa recall (Z-0716-2008)GE OEC Medical Systems, Inc2008-03-15
GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, S recall (Z-0717-2008)GE OEC Medical Systems, Inc2008-03-15
GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Hea recall (Z-0183-2008)GE OEC Medical Systems, Inc2008-01-23
GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regula recall (Z-0181-2008)GE OEC Medical Systems, Inc2007-11-10
OEC 9900 Elite image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, recall (Z-0676-2007)GE OEC Medical Systems, Inc2007-09-28
OEC 9800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. recall (Z-0677-2007)GE OEC Medical Systems, Inc2007-09-28
OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT. recall (Z-0678-2007)GE OEC Medical Systems, Inc2007-09-28
OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE recall (Z-0679-2007)GE OEC Medical Systems, Inc2007-09-28
OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, GE Healthcare, Salt recall (Z-0680-2007)GE OEC Medical Systems, Inc2007-09-28
OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, GE Health recall (Z-0681-2007)GE OEC Medical Systems, Inc2007-09-28
OEC 9800 Plus (Fluorotrak), Image-intensified fluoroscopic x-ray system, GE Healthcare, Sa recall (Z-0682-2007)GE OEC Medical Systems, Inc2007-09-28
OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake recall (Z-0683-2007)GE OEC Medical Systems, Inc2007-09-28
Cleaning probe included as an accessory to aspirators that are sterile packed single use d recall (Z-1130-2007)GE OEC Medical Systems, Inc2007-08-07
GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, recall (Z-0989-2007)GE OEC Medical Systems, Inc2007-07-12
GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, GE Healthcare, Salt Lake City, UT. recall (Z-0990-2007)GE OEC Medical Systems, Inc2007-07-12
GE OEC 9900 Elite Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. recall (Z-0848-2007)GE OEC Medical Systems, Inc2007-06-30
GE OEC 9800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. recall (Z-0849-2007)GE OEC Medical Systems, Inc2007-06-30
GE OEC 8800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah recall (Z-0850-2007)GE OEC Medical Systems, Inc2007-06-30
GE OEC 6800 Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. recall (Z-0851-2007)GE OEC Medical Systems, Inc2007-06-30
GE OEC 2800 mobile Fluoroscopic X-ray System, GE Healthcare, Salt Lake City, Utah. recall (Z-0852-2007)GE OEC Medical Systems, Inc2007-06-30
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anato recall (Z-0704-2007)GE OEC Medical Systems,Inc2007-03-30
OEC 9800 Fluoroscopic X-ray System, Model Number A349855, GE Healthcare, Surgery. recall (Z-0556-2007)GE OEC Medical Systems, Inc2007-03-22
OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, recall (Z-0557-2007)GE OEC Medical Systems, Inc2007-03-22
OEC 9800 Plus Fluoroscopic X-ray System, recall (Z-0558-2007)GE OEC Medical Systems, Inc2007-03-22
OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, recall (Z-0559-2007)GE OEC Medical Systems, Inc2007-03-22
OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 88208 recall (Z-0514-2007)GE OEC Medical Systems, Inc2007-02-15
OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Won recall (Z-0515-2007)GE OEC Medical Systems, Inc2007-02-15
GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation,GE OEC Medical Systems Inc recall (Z-0041-2007)GE OEC Medical Systems, Inc2006-10-25
OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, recall (Z-0042-2007)GE OEC Medical Systems, Inc2006-10-14
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC recall (Z-0001-2007)GE OEC Medical Systems, Inc2006-10-03
MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system. recall (Z-0704-06)GE OEC Medical Systems,Inc2006-09-30
GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, GE OEC Medical Systems Inc. recall (Z-1301-06)GE OEC Medical Systems, Inc2006-09-30
GE OEC 9800 Fluoro C-Arm X-ray System, GE OEC Medical Systems Inc. recall (Z-1302-06)GE OEC Medical Systems, Inc2006-09-30
RUS Tool Version Software recall (Z-1303-06)GE OEC Medical Systems, Inc2006-09-30
GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin T recall (Z-0709-06)GE OEC Medical Systems,Inc2006-04-07
ENTrak Navigation and Visualization System recall (Z-0812-05)GE OEC Medical Systems,Inc2005-05-11
ENTrak Plus Navigation and Visualization System recall (Z-0813-05)GE OEC Medical Systems,Inc2005-05-11
InstaTrak 3500 Navigation and Visualization System recall (Z-0814-05)GE OEC Medical Systems,Inc2005-05-11
InstaTrak 3500 Plus Navigation and Visualization System recall (Z-0815-05)GE OEC Medical Systems,Inc2005-05-11
Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spin recall (Z-0155-05)GE OEC Medical Systems,Inc2004-11-03
Uroview 2000 X-ray System recall (Z-0945-03)GE OEC Medical Systems,Inc2003-06-21
Uroview 2500 X-ray System recall (Z-0946-03)GE OEC Medical Systems,Inc2003-06-21
Uroview 2600 Uroview System recall (Z-0947-03)GE OEC Medical Systems,Inc2003-06-21

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Every clearance here is in the API, with alerts when new ones post.