Events

Recall of Device Recall Phoenix micromelx and nanomelx 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
    73364
  • Event Risk Class
    Class 2
  • Event Number
    Z-1231-2016
  • Event Initiated Date
    2015-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143968
  • 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
    Ge inspection technologies, lp ("ge") has discovered that certain of its cabinet x-ray systems may not fully comply with the food and drug administration's (fda) cabinet x¿ ray system performance standards, 21 c.F.R. ¿ 1020.40(c)(1)(i).
  • Action
    GE Inspection Technologies Planned Action to bring into Compliance: 1. GE Inspection Technologies will use their updated adhesive procedure to install new brackets to the bottom left and right lead strips in the control door. The new procedure and brackets were developed in November 2013. 2. A second notification of customers with affected systems will be sent within 5 days of approval of this CAP. This notification will describe the repair above and propose that a GE technician visit each site and install the described repair. 3. Repairs will be completed within 120 days after approval of this CAP and will be made free of charge. For further questions, please call (717) 447-1278. ;

Device

Device Recall Phoenix micromelx and nanomelx cabinet xray systems
  • Model / Serial
    phoenix micrornelx and nanomelx cabinet x-ray systems
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.
  • Product Description
    GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
  • 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