Events

Recall of Pentax OF-B194 Gas/Water Feeding Valve

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Hoya Healthcare 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
    15293
  • Event Initiated Date
    2013-08-29
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    The reported defect may not cause stoppage of the supply of co2 gas during an endoscopic procedure with the potential for serious hazard to the patient and/or user, which is the result of a manufacturing assembly failure, which cannot be corrected at your facility.
  • Action
    Product to be exchanged

Device

Pentax OF-B194 Gas/Water Feeding Valve

Manufacturer

Hoya Healthcare Corporation
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    NZMMDSA