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 of America 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
    75306
  • Event Risk Class
    Class 2
  • Event Number
    Z-0636-2017
  • Event Initiated Date
    2016-08-15
  • Event Date Posted
    2016-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150012
  • 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
    Colonoscope and accessories, flexible/rigid - Product Code FDF
  • Reason
    Pentax is initiating the product correction of several model numbers of pentax's colonoscope that were shipped between the clearance date of april 2014 and september 2015 because they contain the operation and reprocessing ifu's that were in use prior to the 2014 clearances and therefore did not include the cleared operation ifu, the updated reprocessing ifu or the dedicated reprocessing adaptor (for applicable models).
  • Action
    Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.

Device

Pentax
  • Model / Serial
    Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide and Japan
  • Product Description
    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.
  • Manufacturer
    Pentax of America Inc

Manufacturer

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