Events

Recall of Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems.

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
    74554
  • Event Risk Class
    Class 2
  • Event Number
    Z-2236-2016
  • Event Initiated Date
    2016-03-02
  • Event Date Posted
    2016-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147897
  • 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
    Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. the identified cause was insufficient attachment of shielding in the door. jostling during delivery was identified as the probable cause of this failure to comply with the performance standard.
  • Action
    GE plans to notify its customers with the systems through a TIL. The TIL will inform customers that GE will add lead strips to the inside window frame under the lead glass window of the main cabinet door. GE recommends that it visit each customer site and repair the system by adding lead strips along the window frame of the cabinet door, beneath the lead glass window, within 90 days following FDA's approval of the repair plan.

Device

Device Recall GE Inspection Technologies Phoenix vtomex M240 cabinet xray systems.
  • Model / Serial
    SN - PA2384
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : FL, TN, and TX.
  • Product Description
    GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. || A microfocus CT system used primarily for 3D metrology and analysis.
  • 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