Events

Recall of Device Recall GE Precision MPi

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Regulatory Insight, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0753-2016
  • Event Initiated Date
    2008-07-01
  • Event Date Posted
    2016-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141343
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    It was discovered that the remote touch panel (rtp) of the ge precision mpi x-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
  • Action
    Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance: 1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect. 2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective. 3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance. For further questions please call (720) 962- 5412.

Device

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

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