Events

Recall of Device Recall DCI

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dental Equipment 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
    38169
  • Event Risk Class
    Class 2
  • Event Number
    Z-1077-2007
  • Event Initiated Date
    2007-05-01
  • Event Date Posted
    2007-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53090
  • 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
    dental light - Product Code EAZ
  • Reason
    Potential for light shield to melt due to light assemblies not properly rated to handle the vac.
  • Action
    On 5/1/07 the dental office contacted the manufacturer via telephone regarding the incident. On 5/2/07 the firm's service representative visited the dental office and replaced the lights.

Device

Device Recall DCI
  • Model / Serial
    All products of this type. Product does not contain serial numbers or any other identifying codes.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The lights were distributed to one distributor in NY who in turn distributed the lights to one dental office.
  • Product Description
    DCI Equipment Track Mount Light Assembly, 110v
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • Manufacturer Address
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA