Events

Recall of J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BOVIE MEDICAL CORPORATION.

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
    30411
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-09
  • 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
    Bovie medical has become aware of an issue caused by incomplete insertion of the j-plasma handpiece cable plug into the generator receptacle. when the j-plasma handpiece with generator is used during surgical procedures without the cable plug being completely inserted into thgenerator the green indicator light to the left of the receptacle will illuminate event with an incomplete cable plug insertion. there have been no patient injuries reported as a result of this issue.

Device

J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP
  • Model / Serial
    Model Catalog: BVX-330B (Lot serial: ALL); Model Catalog: BVX-270B (Lot serial: ALL); Model Catalog: BVX-330BR (Lot serial: ALL); Model Catalog: BVX-150BPP (Lot serial: ALL); Model Catalog: BVX-150B (Lot serial: ALL)
  • Product Description
    J-PLASMA HANDPIECE BLADE TIP PISTOL GRIP
  • Manufacturer
    BOVIE MEDICAL CORPORATION

Manufacturer

BOVIE MEDICAL CORPORATION