Events

Recall of Device Recall Pentax Medical Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pentax Medical Company.

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
    68753
  • Event Risk Class
    Class 2
  • Event Number
    Z-2290-2014
  • Event Initiated Date
    2014-07-17
  • Event Date Posted
    2014-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128601
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endoscope and/or accessories - Product Code KOG
  • Reason
    The instructions for use for the pentax of-b130 and of-b194 gas/water valve ifu if not followed carefully may cause a potential risk to health.
  • Action
    Pentax Medical sent an Urgent Medical Device Recall Field Safety Corrective Action letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the Instruction for Use are not followed carefully by the user there is a potential risk to health for the patient, such as a perforation. Customers are asked to complete the attached response form and fax to (201) 799-4063. Customers should see the attached revised Instructions for Use Z632 R09. If you have any questions regarding this action, please feel free to contact your Sales Representative at : 800-431-5880 ext 2064

Device

Device Recall Pentax Medical Inc.
  • Model / Serial
    Model No. OF-B130 OF-B194, all units.
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
  • Product Description
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
  • Manufacturer
    Pentax Medical Company

Manufacturer

Pentax Medical Company
  • Manufacturer Address
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA