Events

Recall of Device Recall Phoenix x/ray analyser series

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
    52193
  • Event Risk Class
    Class 2
  • Event Number
    Z-1825-2011
  • Event Initiated Date
    2009-03-16
  • Event Date Posted
    2011-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82487
  • 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 explosive detection systems - Product Code RCE
  • Reason
    Some of the systems do not have a safety interlock on the service access panel. although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. also, some systems lack proper placement of a caution label and others do not have this label affixed.
  • Action
    The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.

Device

Device Recall Phoenix x/ray analyser series
  • Model / Serial
    All affected units.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Phoenix x/ray analyser series. || Phoenix x|ray analyser series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.
  • 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