Events

Recall of BLUEPHASE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IVOCLAR VIVADENT 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
    24935
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-10
  • 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
    In two cases to date a very rare combination of swelling of the battery cell with a ridge on the inside plastic housing of the battery caused a chain reaction allowing energy in the handpiece battery to be released thus destroying the device and causing smoke damage.

Device

BLUEPHASE
  • Model / Serial
    Model Catalog: 608532 (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 613752BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 613735BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 607921BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 607920BU (Lot serial: 603752BU: 400000 TO 400705); Model Catalog: 627300 (Lot serial: 608535:00001 TO 024999); Model Catalog: 613753 (Lot serial: 608535:00001 TO 024999); Model Catalog: 608535 (Lot serial: 608535:00001 TO 024999); Model Catalog: 608532 (Lot serial: 608535:00001 TO 024999); Model Catalog: 613752BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 613735BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 607921BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 607920BU (Lot serial: 608535:00001 TO 024999); Model Catalog: 627300 (Lot serial: 607921BU:FROM 100000 TO 103280); Model Catalog: 613753 (Lot serial: 607921BU:FROM 100000 TO 103280); Model Catalog: 608535 (Lot serial: 607921BU:FROM 100000 TO 103280); Mod
  • Product Description
    BLUEPHASE
  • Manufacturer
    IVOCLAR VIVADENT INC.

Manufacturer

IVOCLAR VIVADENT INC.