Events

Recall of Device Recall LumiWave Infrared lamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biocare Systems 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
    35780
  • Event Risk Class
    Class 2
  • Event Number
    Z-1419-06
  • Event Initiated Date
    2006-06-14
  • Event Date Posted
    2006-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46861
  • 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
    Infrared lamp - Product Code ILY
  • Reason
    Electrical safety hazard-when pulling on the cord of the ac adapter, to remove it from an outlet, the prongs on the ac adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard.
  • Action
    Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.

Device

Device Recall LumiWave Infrared lamp
  • Model / Serial
    Catalog # LW1X4, all units, all lots
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.
  • Product Description
    LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.
  • Manufacturer
    Biocare Systems Inc.

Manufacturer

Biocare Systems Inc.
  • Manufacturer Address
    Biocare Systems Inc., 9853 Paperflower Drive, Parker CO 80138
  • Manufacturer Parent Company (2017)
    Biocare Systems Inc
  • Source
    USFDA