Devices

Device Recall GE Precision MPi

  • Model / Serial
    NRT no.: 02980000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
  • Product Description
    GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
  • Manufacturer
    Regulatory Insight, Inc
  • 1 Event

Manufacturer

Regulatory Insight, Inc
  • Manufacturer Address
    Regulatory Insight, Inc, 33 Golden Eagle Ln, Littleton CO 80127-5745
  • Manufacturer Parent Company (2017)
    Regulatory Insight Inc
  • Source
    USFDA

2 devices with a similar name

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Device Recall GE Precision MPi
  • Model / Serial
    serial numbers: 507001, 507002, 507003, 507004, 507005, 507006, 507007, 507008, 510001, 510002, 510003, 510004, 510005, 510006, 510007, 510008, 510009, 510010, 513001, 513002, 513004, 513005, 513006, 513007, 513008, 513009, 513010, 513011, 518002, 518003, 518004, 518005, 518006, 518007, 518008, 518009, 518010, 518011, 518012, 518013, 518014, 518015, 518016, 518017, 518018, 518019, 518020, 522001, 522002, 522003, 522004, 522005, 522006, and 522008.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
  • Product Description
    GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA || The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
  • Manufacturer
    GE Healthcare
Device Recall GE Precision MPi
  • Model / Serial
    to follow
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
  • Product Description
    GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA || The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
  • Manufacturer
    GE Healthcare