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Crédits
Manufacturers
General Electric Med Systems LLC
Adresse du fabricant
General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Source
USFDA
23 Events
Rappel de Image Processing System
Rappel de GE LOGIQ Book
Rappel de GE LOGIQ 5
Rappel de GE CT system
Rappel de Millennium VG, Discovery VH, Varicam
Rappel de Device Recall Proteus XR/a Radiographic System
Rappel de Device Recall GE Healthcare Innova
Rappel de Device Recall GE Healthcare Innova
Rappel de Device Recall GE Healthcare Innova
Rappel de Device Recall GE Healthcare Innova 3100/ 3100 IQ
Rappel de Device Recall GE Healthcare Innova 2100 IQ
Rappel de Device Recall GE Healthcare Innova 2100 IQ
Rappel de Device Recall GE Healthcare Innova 3100/ 3100 IQ
Rappel de Device Recall GE Healthcare Innova 4100/4100 IQ
Rappel de Device Recall Silhouette FC (currently marketed as Proteus XR/a)
Rappel de Device Recall Definium 8000
Rappel de Device Recall Revolution XR/d
Rappel de Device Recall Diamond Mammographic XRay System
Rappel de Sopha Medical Vision DST / DSTXL Nuclear Cameras
Rappel de Device Recall GE Precision 500D
Rappel de Device Recall GE Discovery ST PET/CT
Rappel de Device Recall Precision 500D Radiographic/Fluoroscopic Xray
Rappel de Device Recall Proteus XR/a Radiographic Xray System
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23 dispositifs dans la base de données
Image Processing System
Modèle / numéro de série
100943VP0, 67392II1, 36521VE3, 70827VE1, 419453BU6436332BU1, 70800VE8, 44586VE6, 341GE8, 97197VP8, 99813VP8, 97983VP1, 70820VE6, 58626VE3, 70795VE0, FRB3510J25, 58630VE5, 58624VE8, 58589VE3, 7823VE0, 44579VE1, 44597VE3, 44585VE8, 25125VE6, 425022BU1, 70796VE8, 93086VE7, 37621BU4, 76906VE7, 76899VE4, 70798VE4, 65504VE3, 65603VE3, 36543VE7, 58628VE9, 70811VE5, 44584VE1, 44581VE7, FRB3430VBM, 44589VE0, 44598VE1, 44582VE5, 44594VE0, 72740VE4, 1189GE0, 2030GE5, 2085GE0, 2025GE5, 72477II3, 72480II7, 343GE4, 97203VP4, 98272VP8, 423277BU3, 349GE1, 425018BU9, FRB3300M6G, 99699VP1, 98371VP8, 101216VP0, 425015BU5, 237GE8, 364GE0, 339GE2, 101196VP4, 419382BU7, 419383BU5, 366GE5, 367GE3, 357GE4, 2085GE9, 419457BU7, 25128VE0, 98436VP9, 99981VP3, 36513VE0, 98623UP2, 101000VP8, 2028GE9, 2799GE5, 1089GE2, 419450BU2, 101280VP6, 67269VE1, 100855VP6, 66250II2, 346GE7, 363GE2, 345GE9, 1073VP5, 101170VP9, 98516VP8, 2802GE7, 419356BU1, 66244II5, 1487GE8, 67389II7, 365GE7, 425021BU3, 383GE0, 25132VE2, 101334VP1, 95972VP6, 419449BU4, 2031GE3, 2800GE1, 36517VE1, FRB33605L9, 1024GE9, 95307VP5, 102235VP9, 102232VP6, 425204BU5, 1124GE7, 1122GE1, 419455BU1, 419456BU9, 102220VP1, 102555VP0, 97622VP5, 72249II6, 67210VE5, FRB33605KX, 419257BU1, 95268VP9, 338GE4, 101404VP2, 2090GE9, 2087GE5, 101308VP5, 101251VP7, 421989BU5, 342GE6, 99627VP2, 97933VP6, 98653VP9, 66249II4, 72479II9, 25126VE4, 356GE6, 25130VE6, 65450VE9, DE31500056, 347GE5, 421367BU4, 100912VP5, 25123VE1, 25124VE9, 99867VP4, DE24600031, 99910VP2, 101246VP7, 419357BU9, 101171VP7, 102825VP7, 100664VP2, 102856VP2, 424101BU4, 425020BU5, 354GE1, 36518VE9, 100885VP3, 2801GE9, USV41104ST, 2091GE7, USV41103MJ, 99994VP6, 102133VP6, 419549BU1, 25137VE1, 102078VP3, 425351BU4, 1066GE0, 98816VP2, 97591VP2, 99631VP4, 423318BU5, 2086GE7, 97905VP4, 100690VP7, 350GE9, 25139VE7, 1120GE5, 100001VP7, 2084GE2, 391228BU4, 101190VP7, 99909VP4, 1123GE9, 2803GE5, 98474VP0, 25127VE2, 67384II8, 98815VP4, 101288VP9, 101287VP1, 66241II1, 25134VE8
Classification du dispositif
Radiology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Distributed in 32 states: AK, AL, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV; Australia, Belgium, Brazil, Canada, Switzerland, Chile, Nigeria, China, France, Egypt, Ireland, Israel, Japan, Korea, the Netherlands, Norway, New Zealand, Phillipines, Sweden, and Taiwan.
Description du dispositif
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
GE LOGIQ Book
Modèle / numéro de série
all serial numbers
Classification du dispositif
Radiology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
nationwide and worldwide
Description du dispositif
LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
GE LOGIQ 5
Modèle / numéro de série
all serial numbers
Classification du dispositif
Radiology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
nationwide and worldwide
Description du dispositif
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
GE CT system
Modèle / numéro de série
Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2
Classification du dispositif
Radiology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Description du dispositif
Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
Millennium VG, Discovery VH, Varicam
Modèle / numéro de série
Each unit has a unique serial code. All serial numbers are being recalled.
Classification du dispositif
Radiology Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Nationwide throughout the United States and worldwide.
Description du dispositif
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
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