Events

Recall of Device Recall GC80 Digital Xray Imaging System

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
    78679
  • Event Risk Class
    Class 2
  • Event Number
    Z-0726-2018
  • Event Initiated Date
    2017-06-22
  • 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=160105
  • 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
    System, x-ray, stationary - Product Code KPR
  • Reason
    An image was obtained with over exposure during a thorax examination using the aec function.
  • Action
    On June 22, 2017, Samsung distributed Urgent Field Safety Notices & acknowledgment forms to their customers via email. INSTRUCTIONS FOR END USERS: 1) Please read the Field Safety Notice documentation in detail. 2) Follow the instructions provided in this FSN in relation to any actions which are required of you. 3) Complete the provided acknowledgement form and return to your supplier as soon as possible. Your organizations reply is the evidence we need to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the Field Safety Notice documentation in detail. 2) Please review and complete the acknowledgement form provided in this FSN and return to Samsung as soon as possible. Please pass this entire package of FSN documentation onto your customers and ask them to return the completed acknowledgement form. Please forward copies of acknowledgements from end users onto to the email addresses stated above. Samsung require this evidence to monitor the progress of the corrective actions. 4) If required and instructed by this FSN documentation, please undertake all relevant service actions as soon as is practicably possible. Customers with questions were advised to contact their local representative.

Device

Device Recall GC80 Digital Xray Imaging System
  • Model / Serial
    Accession Number 1310459
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide US
  • Product Description
    The GC80 Digital X-ray Imaging System
  • 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