Events

Recall of Pentax

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
    73894
  • Event Risk Class
    Class 2
  • Event Number
    Z-2074-2016
  • Event Initiated Date
    2016-04-06
  • Event Date Posted
    2016-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145359
  • 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
    Nasopharyngoscope (flexible or rigid) - Product Code EOB
  • Reason
    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.G., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
  • Action
    Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.

Device

Pentax
  • Model / Serial
    Model #'s FNL-10RAP, FNL-13RAP, FNL-15RP3 and VNL-1530T
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Product Description
    Naso-Pharyngo-Laryngoscope || Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations
  • 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