Events

Recall of Device Recall GMR40

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

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
    79628
  • Event Risk Class
    Class 2
  • Event Number
    Z-1391-2018
  • Event Initiated Date
    2018-01-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162862
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
  • Action
    A field safety notice was sent stating that the manufacturer, without charge, will remedy the defect. The notice stated that field upgrades would be performed by December 31, 2017. The notice provided instructions to end users and to distributors. For further questions, please call (978) 564-8503.

Device

Device Recall GMR40
  • Model / Serial
    Model Number GMR40. Serial numbers 00001 through 00016.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution . Only one consignee was shipped 16 units of the affected device.
  • Product Description
    Solid state x-ray imager (flat panel/digital imager) || Solid state x-ray imager (flat panel/digital imager) || Medical
  • Manufacturer
    NeuroLogica Corporation

Manufacturer

NeuroLogica Corporation
  • Manufacturer Address
    NeuroLogica Corporation, 14 Electronics Ave, Danvers MA 01923-1011
  • Manufacturer Parent Company (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA