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Credits
Manufacturers
General Electric Med Systems LLC
Manufacturer Address
General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
Source
USFDA
23 Events
Recall of Image Processing System
Recall of GE LOGIQ Book
Recall of GE LOGIQ 5
Recall of GE CT system
Recall of Millennium VG, Discovery VH, Varicam
Recall of Device Recall Proteus XR/a Radiographic System
Recall of Device Recall GE Healthcare Innova
Recall of Device Recall GE Healthcare Innova
Recall of Device Recall GE Healthcare Innova
Recall of Device Recall GE Healthcare Innova 3100/ 3100 IQ
Recall of Device Recall GE Healthcare Innova 2100 IQ
Recall of Device Recall GE Healthcare Innova 2100 IQ
Recall of Device Recall GE Healthcare Innova 3100/ 3100 IQ
Recall of Device Recall GE Healthcare Innova 4100/4100 IQ
Recall of Device Recall Silhouette FC (currently marketed as Proteus XR/a)
Recall of Device Recall Definium 8000
Recall of Device Recall Revolution XR/d
Recall of Device Recall Diamond Mammographic XRay System
Recall of Sopha Medical Vision DST / DSTXL Nuclear Cameras
Recall of Device Recall GE Precision 500D
Recall of Device Recall GE Discovery ST PET/CT
Recall of Device Recall Precision 500D Radiographic/Fluoroscopic Xray
Recall of Device Recall Proteus XR/a Radiographic Xray System
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23 devices in the database
Image Processing System
Model / Serial
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
Product Classification
Radiology Devices
Device Class
2
Implanted device?
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.
Product Description
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
Model / Serial
all serial numbers
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
nationwide and worldwide
Product Description
LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
GE LOGIQ 5
Model / Serial
all serial numbers
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
nationwide and worldwide
Product Description
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
GE CT system
Model / Serial
Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Product Description
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
Model / Serial
Each unit has a unique serial code. All serial numbers are being recalled.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide throughout the United States and worldwide.
Product Description
Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
18 more
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