Events

Recall of Device Recall Olympus VISERA OTVS7V Camera Head

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus 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
    56593
  • Event Risk Class
    Class 2
  • Event Number
    Z-2642-2010
  • Event Initiated Date
    2010-08-20
  • Event Date Posted
    2010-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94059
  • 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
    Laparoscope, General & Plastic Surgery - Product Code GCJ
  • Reason
    Mislabeled. endoscopic body-type camera heads labeled as cardiac-type.
  • Action
    Asked consignees to return camera heads to correct the labeling.

Device

Device Recall Olympus VISERA OTVS7V Camera Head
  • Model / Serial
    Models: OTV-S7H-1D-L08E and OTV-S7H-1D-F08E; serviced by recalling firm from 3/03 to 9/07
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide; camera heads were serviced and returned to consignees in March 2003 - September 2007 timeframe
  • Product Description
    Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to be used with Olympus endoscopic equipment)
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA