Events

Recall of Device Recall Bladeline 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
    77756
  • Event Risk Class
    Class 2
  • Event Number
    Z-2777-2017
  • Event Initiated Date
    2017-06-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157833
  • 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 determined that the blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliroentgen in one hour (21 cfr ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. the crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.
  • Action
    GE Inspection Technologies will bring the defect into compliance: 1. Four panels of sheet metal/lead/sheet metal construction (6 mm lead thickness) will be permanently mounted using an industrial epoxy to the inside floor of the cabinet to prevent emissions from exceeding the limit in the performance standard. A radiation emission measurement will be made following the repairs of each system to assure the issue was corrected. 2. GE will notify affected customers within 5 days of GEs receipt of this approval letter. 3. The notification will recommend that customers allow GE to visit the site and install the new shielding within 120 days following GEs receipt of this letter. 4.The text of the notification to customers will include the required statement that confirms that GE will, without charge, bring the affected cabinet x-ray systems into compliance with the performance standard. For further questions, please call (717) 447-1278.

Device

Device Recall Bladeline Cabinet Xray system
  • Model / Serial
    Serial No.  TM 201317 TM 201312 TM 201323 TM 201331 TM 201401 TM 201329 TM 201404 TM 201413 TM 201414 TM 201415 TM 201424 TM 201425 158017R1
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
  • Product Description
    GE Inspection Technologies Blade|line Industrial 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