Events

Recall of Device Recall Waterlase MD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biolase Technology 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
    31106
  • Event Risk Class
    Class 3
  • Event Number
    Z-0543-05
  • Event Initiated Date
    2005-01-17
  • Event Date Posted
    2005-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37154
  • 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
    Laser, Dental - Product Code LYB
  • Reason
    Reports that the waterlase md, a dental laser unit, water bottle broke under pressure during installation.
  • Action
    Water bottles will be replaced by trained Biolase representatives. During that visit, the representative will verify that the bottle pressure is set correctly and the existing bottle is replaced with a new bottle.

Device

Device Recall Waterlase MD
  • Model / Serial
    Model #6200218; Serial Numbers: 10500210 to 10502680, inclusive.
  • Product Classification
    Dental Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Germany, Ireland, France, United Arab Emirates, Lebanon, Greece, Hong Kong, Argentina, Indonesia, Estonia, Spain, Taiwan
  • Product Description
    Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
  • Manufacturer
    Biolase Technology Inc

Manufacturer

Biolase Technology Inc
  • Manufacturer Address
    Biolase Technology Inc, 981 Calle Amanecer, San Clemente CA 92673-6212
  • Source
    USFDA