Events

Recall of Device Recall GE Cabinet Xray system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Inspection Technologies, LP.

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
    70478
  • Event Risk Class
    Class 2
  • Event Number
    Z-1225-2015
  • Event Initiated Date
    2015-01-13
  • Event Date Posted
    2015-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134149
  • 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
    Cabinet x-ray, industrial - Product Code RCE
  • Reason
    It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
  • Action
    GE Inspection Technologies, Planned Action: 1. GE will notify customers of the affected cabinet x-ray systems through a Technical Information Letter. GE notified its affected customers via email on January 13, 2015, via letter dated January 14, 2015, and via telephone on January 19, 2015. 2.GE will install an interim insert within 30 days of receipt of this letter. The insert will cover any existing or interim gaps in the original lead shielding on the door. 3. GE will replace the doors of affected cabinet x-ray systems no later than 180 day of receipt of this letter. 4. These corrections will be made free of charge. The Technical Information Letter used for notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter For further questions, please call (717) 447-1278

Device

Device Recall GE Cabinet Xray system
  • Model / Serial
    SN - PA1053
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of OH and PA.
  • Product Description
    GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
  • Manufacturer
    GE Inspection Technologies, LP

Manufacturer

GE Inspection Technologies, LP
  • Manufacturer Address
    GE Inspection Technologies, LP, 50 Industrial Park Rd, Lewistown PA 17044-9312
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA