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GE Healthcare

185 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of an recall (Z-1634-2009)GE Healthcare2009-07-30
Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation anaesthes recall (Z-1635-2009)GE Healthcare2009-07-30
GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine. recall (Z-1425-2009)GE Healthcare2009-06-23
GE Datex-Ohmeda Advance Anesthesia Gas-Machine. recall (Z-1426-2009)GE Healthcare2009-06-23
GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring. recall (Z-1227-2009)GE Healthcare2009-06-01
GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and recall (Z-1039-2009)GE Healthcare2009-04-06
GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system recall (Z-0285-2009)GE Healthcare2009-01-05
GE Healthcare, Mobile Care Server used in conjunction with Web Viewer, Pocket Viewer, and recall (Z-0213-2009)GE Healthcare2008-11-05
Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, recall (Z-0200-2009)GE Healthcare2008-10-27
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827. recall (Z-1713-2008)GE Healthcare2008-09-30
GE Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option. recall (Z-1516-2008)GE Healthcare2008-09-29
GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing option. recall (Z-1517-2008)GE Healthcare2008-09-29
GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammograp recall (Z-2146-2008)GE Healthcare2008-09-26
GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammograp recall (Z-2147-2008)GE Healthcare2008-09-26
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution recall (Z-1822-2008)GE Healthcare2008-09-25
GE Healthcare Definium 8000 Digital Radiographic System. recall (Z-1882-2008)GE Healthcare2008-09-25
GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthca recall (Z-1883-2008)GE Healthcare2008-09-25
GE Datex-Ohmeda Engstrom Carestation The Carestation consists of three main components: a recall (Z-1829-2008)GE Healthcare2008-09-24
GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6 recall (Z-2404-2008)GE Healthcare2008-09-22
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-2356-2008)GE Healthcare2008-09-21
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-2357-2008)GE Healthcare2008-09-21
GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an recall (Z-2358-2008)GE Healthcare2008-09-21
Advantx-E The Advantx imaging system is intended to be used for general purpose diagnostic recall (Z-2359-2008)GE Healthcare2008-09-21
Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems a recall (Z-2360-2008)GE Healthcare2008-09-21
Innova 2000 The principle system components include a C-arm, image acquisition, processing recall (Z-2361-2008)GE Healthcare2008-09-21
Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. recall (Z-2312-2008)GE Healthcare2008-09-20
Innova 2000; The principle system components include a C-arm, image acquisition, processin recall (Z-2435-2008)GE Healthcare2008-09-20
Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane position recall (Z-2436-2008)GE Healthcare2008-09-20
Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (T recall (Z-2437-2008)GE Healthcare2008-09-20
Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188 (The system consists of an a mon recall (Z-2438-2008)GE Healthcare2008-09-20
GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495, 2336900, 23 recall (Z-1610-2008)GE Healthcare2008-09-19
Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 218 recall (Z-1611-2008)GE Healthcare2008-09-19
GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The product recall (Z-2142-2008)GE Healthcare2008-09-19
GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product recall (Z-2143-2008)GE Healthcare2008-09-19
GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The product recall (Z-2144-2008)GE Healthcare2008-09-19
GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical System recall (Z-2145-2008)GE Healthcare2008-09-19
GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North recall (Z-1476-2008)GE Healthcare2008-09-18
GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, recall (Z-1477-2008)GE Healthcare2008-09-18
GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to recall (Z-1890-2008)GE Healthcare2008-09-17
GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a di recall (Z-1891-2008)GE Healthcare2008-09-17
Advantx-E is an angiographic X-Ray system. recall (Z-2038-2008)GE Healthcare2008-09-16
Innova 2100IQ is a Digital Fluoroscopic Imaging System that consists of an a monoplane pos recall (Z-2039-2008)GE Healthcare2008-09-16
Innova 3100/3100IQ is a cardiovascular Imaging System. The system consists of an a monopla recall (Z-2040-2008)GE Healthcare2008-09-16
Innova 4100/4100IQ is a X-Ray system that consists of an a monoplane positioner, a vascula recall (Z-2041-2008)GE Healthcare2008-09-16
Innova 2000's principle system components include a C-arm, image acquisition, processing a recall (Z-2042-2008)GE Healthcare2008-09-16
Innova 2121-1Q/3131-1Q is a Biplane Cardiovascular Imaging System. The Innova Biplane syst recall (Z-2043-2008)GE Healthcare2008-09-16
GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. In recall (Z-2210-2008)GE Healthcare2008-09-16
GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers 5107849, 510 recall (Z-2211-2008)GE Healthcare2008-09-16
GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 239500 recall (Z-2225-2008)GE Healthcare2008-09-11
DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contourin recall (Z-2008-2008)GE Healthcare2008-09-05
GE Precision 500D Classical Radiographic-Fluoroscopic X-ray System. Model #2289299-2, with recall (Z-0369-2008)GE Healthcare2008-09-04
GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model numbers 5220493. Th recall (Z-1133-2008)GE Healthcare2008-09-04
GE Healthcare Definium 5000 Digital Radiographic Imaging System. Model number 5220493-2. T recall (Z-1134-2008)GE Healthcare2008-09-04
GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analo recall (Z-1563-2008)GE Healthcare2008-08-24
GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a remote R&F sy recall (Z-1564-2008)GE Healthcare2008-08-24
GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote anal recall (Z-1565-2008)GE Healthcare2008-08-24
Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x recall (Z-0274-2008)GE Healthcare2008-08-02
S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L recall (Z-1161-2008)GE Healthcare2008-06-24
GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously mar recall (Z-0842-2008)GE Healthcare2008-06-10
GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha, W recall (Z-0690-2008)GE Healthcare2008-01-31
GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 recall (Z-0691-2008)GE Healthcare2008-01-31
GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an recall (Z-0692-2008)GE Healthcare2008-01-31
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume recall (Z-0265-2008)GE Healthcare2007-11-28
Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, an recall (Z-0075-2008)GE Healthcare2007-11-08
GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICO recall (Z-0113-2008)Ge Healthcare2007-11-07
Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, recall (Z-0170-2008)GE Healthcare2007-11-07
GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imag recall (Z-1088-2007)GE Healthcare2007-09-28
GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner Syst recall (Z-0802-2007)GE Healthcare2007-05-15
GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system. recall (Z-0803-2007)GE Healthcare2007-05-15
GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739 recall (Z-0804-2007)GE Healthcare2007-05-15
GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems. recall (Z-0805-2007)GE Healthcare2007-05-15
GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3. recall (Z-0806-2007)GE Healthcare2007-05-15
The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed recall (Z-0506-2007)GE Healthcare2007-02-15
The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography ap recall (Z-0507-2007)GE Healthcare2007-02-15
ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to recall (Z-0054-2007)Ge Healthcare2006-10-21
GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major compon recall (Z-0055-2007)Ge Healthcare2006-10-20
GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a r recall (Z-1485-06)GE Healthcare2006-09-30
Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anes recall (Z-1196-06)GE Healthcare2006-07-12
GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile v recall (Z-0896-06)GE Healthcare2006-05-24
GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an option, Cardiov recall (Z-0897-06)GE Healthcare2006-05-24
GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an option. Digital recall (Z-0898-06)GE Healthcare2006-05-24
Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) recall (Z-0857-06)GE Healthcare2006-05-09
GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized n recall (Z-0413-06)GE Healthcare2006-01-24
GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modula recall (Z-0414-06)GE Healthcare2006-01-24
GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system i recall (Z-0415-06)GE Healthcare2006-01-24
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Every clearance here is in the API, with alerts when new ones post.