Events

Recall of Digital Video Capture Modules

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
    77137
  • Event Risk Class
    Class 2
  • Event Number
    Z-2743-2017
  • Event Initiated Date
    2017-04-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156545
  • 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
    Transformer, endoscope - Product Code GCW
  • Reason
    Pentax medical did not always provide transformers with 9175 isolation transformers are used with 7245c, 7245c/e, 7245d, 9200cs, 9200ds, 9310hds, and 9400s computer systems.
  • Action
    Pentax notified their customers on 4/13/2017 via USPS.

Device

Digital Video Capture Modules
  • Model / Serial
    80847 38953-09 40156-01 40156-09 40158-15 40669-02 40669-09 40670-05 42094-05 45852-06 46800-05 47452-01 48653-02 48653-03 49242-02 72872-49A 80361-14 80362-01 80362-02 80365-05 80399-05 80399-09 80481-07 80841-02 80842-05 80847-06 80878-07 80879-06 80879-08 80880-01 80881-05 80883-03 80884-03 80886-06 80886-11 80886-13 80887-02 80887-08
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    9310HD || Digital Video Capture Modules || Product Usage: || The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
  • 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