Events

Recall of PENTAX Endoscopic Accessories

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
    66379
  • Event Risk Class
    Class 1
  • Event Number
    Z-0084-2014
  • Event Initiated Date
    2013-09-16
  • Event Date Posted
    2013-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122221
  • 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
    Insufflator, automatic carbon-dioxide for endoscope - Product Code FCX
  • Reason
    Pentax medical has become aware of a product issue associated with the of-b194 gas/water feeding valve. a manufacturing defect may cause improper stoppage of co2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
  • Action
    PENTAX Medical sent an "Urgent Device Recall" notification letter with /Response forms dated September 16, 2013, via UPS Certified delivery to all affected customers. . The notification identified the affected product; informed the customers of the nature of the issue; advised of potential adverse patient consequences that may occur. The customer was asked to immediately examine their inventory and quarantine product subject to the recall. The customer was instructed to identify and notify their customers if they further distributed the product. The notification instructs users to return the OF-B194 Valves for replacement with corrected product. Customers were asked to complete the attached response form and fax back to Pentax Medical at 1.201.799.4063. An enclosed UPS Airway Bill is to be used to return recalled product. A contact phone number and email address is provided if the customer has questions (1.800.431.5880 xt2064). For questions regarding this recall call 800-431-5880. Pentax issued a press release on 10/31/2013. Pentax posted their press release on their website at www.pentax.com.

Device

PENTAX Endoscopic Accessories
  • Model / Serial
    Model OF-B194
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.
  • Product Description
    PENTAX Endoscopic Accessories. OF-B194. Made in Japan. || PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
  • 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