Events

Recall of Device Recall 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
    77310
  • Event Risk Class
    Class 2
  • Event Number
    Z-2325-2017
  • Event Initiated Date
    2011-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155674
  • 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
    Bronchoscope (flexible or rigid) - Product Code EOQ
  • Reason
    This field action serves to retrospectively document the actions that were taken by pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify fda of these actions taken in 2010-2011.
  • Action
    Customers were visited by members of Pentax America, Inc. field service team. The field service technicians inspected the affected devices, and documented the inspections using the Inspection Record Form (QS-397).

Device

Device Recall Pentax

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