Events

Recall of KAYPENTAX STROBOSCOPY SYSTEM - DIGITAL STROBE (DIGITAL VIDEO CAPTURE MODULE)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTAX CANADA 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
    15384
  • Event Risk Class
    III
  • Event Initiated Date
    2017-05-30
  • 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
    Pentax medical has become aware that some customers may not have been provided with an isolation transformer when they purchased a pentax medical computer system mounted to a cart. the electrical safety requirements for these systems requires the use of an isolation transformer to protect patients from electrical shock.

Device

KAYPENTAX STROBOSCOPY SYSTEM - DIGITAL STROBE (DIGITAL VIDEO CAPTURE MODULE)
  • Model / Serial
    Model Catalog: MODEL 9200C (Lot serial: 41861-16/CDC15A47600); Model Catalog: MODEL 9310HD (Lot serial: 4015609/B4LMQS001473); Model Catalog: MODEL 9200C (Lot serial: 33413-10/81J01621NA)
  • Product Description
    Digital Video Capture Module;HD-DIGITAL VIDEO CAPTURE
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    HC