Events

Recall of DIAGNODENT LASER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by KALTENBACH & VOIGT GMBH.

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
    109467
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Kavo dental gmbh is recalling the '1.007.5158 battery pack rechargeable 6v-3600mah' used in the diagnodent 2095. kavo dental became aware that vibrations during transport and other external influences can lead to an internal electrical short-circuit of the battery pack. this can lead to overheating and therefore melting of the battery packs plastic case.

Device

DIAGNODENT LASER
  • Model / Serial
    Model Catalog: 574-0500 (Lot serial: various lots)
  • Product Description
    1.007.5158 Battery pack for the DIAGNOdent 2095
  • Manufacturer
    KALTENBACH & VOIGT GMBH

Manufacturer

KALTENBACH & VOIGT GMBH