Events

Recall of Device Recall Xray Cabinet Models

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by North Star Imaging Inc.

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
    78254
  • Event Risk Class
    Class 2
  • Event Number
    Z-0063-2018
  • Event Initiated Date
    2017-08-23
  • 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=159021
  • 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 a low-level radiation leak that was found on the nsi x-7000 system.
  • Action
    North Star Imaging will bring defect into compliance by the following : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 3 units will consist of the following: 1. All three customers have been notified that the affected products will be repaired free of charge. 2 .The area where the emission rate could be exceeded will have shielding added until emissions are adequately attenuated under the conditions described above. 3. The repaired systems will be completely surveyed to verify compliance with the cabinet x- ray system performance standards emission limit. 4.All repairs will be completed before February 1, 2018. For further questions, please call (800) 635-8392.

Device

Device Recall Xray Cabinet Models
  • Model / Serial
    Model X-7000
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : PA, OH and KS.
  • Product Description
    North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. || Industrial x-ray imaging of product hardware
  • Manufacturer
    North Star Imaging Inc

Manufacturer

North Star Imaging Inc
  • Manufacturer Address
    North Star Imaging Inc, 19875 S Diamond Lake Rd Ste 10, ROGERS MN 55374-4651
  • Manufacturer Parent Company (2017)
    North Star Imaging Inc.
  • Source
    USFDA