Events

Recall of Samsung GM60A40S

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
    72171
  • Event Risk Class
    Class 2
  • Event Number
    Z-0263-2016
  • Event Initiated Date
    2015-09-14
  • Event Date Posted
    2015-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140082
  • 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, mobile - Product Code IZI
  • Reason
    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. the system can be stopped by releasing the drive handle or by pressing the emergency switch. proper behavior is re-enabled when the system is rebooted.
  • Action
    An Urgent - Field Safety Notice identifying the affected products, problem involved, root cause, and potential hazards, was sent to customers. In the event the issue occurs, users can release the drive handle or press the emergency switch and the unit will stop. Then, reboot the system. If unintended movements occur, please contact local representative. To correct the issue, service engineers will visit to apply the corrective action. For further information or support concerning this problem, contact local representative.

Device

Samsung GM60A40S
  • Model / Serial
    Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E,  50EAM9BG200007F
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of NC, OH, MA, and MO.
  • Product Description
    Samsung GM60A-40S || Intended for use in generating radiographic images of human anatomy.
  • 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