GE Healthcare

  • Model / Serial
    Model No - 5421698
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    GE Healthcare Optima XR 200 amx with Digital Upgrade. || The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, || Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

254 devices with a similar name

Learn more about the data here

  • Model / Serial
    All versions
  • Product Description
    MRI Software
  • Manufacturer
  • Model / Serial
    EVair compressors (M1230847, M1230849) that were provided to GE Healthcare by imtmedical prior to May 30, 2015 may be affected by this issue. See the serial number list provided in the appendix for a full list of affected devices.
  • Product Description
    Compressor
  • Manufacturer
  • Model / Serial
    The following CT Scanners: LightSpeed Ultra (8-slice MDAS), LightSpeed Plus (4-slice MDAS), LightSpeed QX/i (4-slice MDAS), LightSpeed 16 (MDAS Only) The following PET CT Scanners: Discovery ST, Discovery LS
  • Product Description
    CT Scanners, PET CT Scanners
  • Manufacturer
  • Model / Serial
    This correction applies to some units of the following GE Healthcare MRI system types: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Signa Profile, Signa Ovation, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w, Signa PET/MR, MR950.
  • Product Description
    MRI System, full-body, superconducting magnet
  • Manufacturer
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