Events

Recall of Lodox Statscan digital radiographic system.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lodox Na Llc.

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
    28581
  • Event Risk Class
    Class 2
  • Event Number
    Z-0389-04
  • Event Initiated Date
    2004-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32163
  • 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
  • Reason
    The labels do not have proper identification and certification and the firm failed to provide adequate test and quality control procedures to establish certification by the manufacturer.
  • Action
    The device in Illinois was re-exported. The device in Maryland was tested on 5/10/04 by a trained Lodox representative and proper labeling was reportedly attached.

Device

Lodox Statscan digital radiographic system.
  • Model / Serial
    Serial numbers LDX002 and LDX004.
  • Distribution
    Illinois and Maryland.
  • Product Description
    Lodox Statscan digital radiographic system.
  • Manufacturer
    Lodox Na Llc

Manufacturer

Lodox Na Llc
  • Manufacturer Address
    Lodox Na Llc, 23360 Clarkshire Dr, South Lyon MI 48178-8920
  • Source
    USFDA