Events

Recall of Device Recall Optovue RTVue Optical Coherence Tomography with Normative Database

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Optovue 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
    54191
  • Event Risk Class
    Class 2
  • Event Number
    Z-1131-2010
  • Event Initiated Date
    2010-01-08
  • Event Date Posted
    2010-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87800
  • 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
    Tomography, optical coherence - Product Code OBO
  • Reason
    Marketed without proper 510(k)-- no 510(k) clearance for optovue rtvue model-rt100 with software versions 3.0.X.X and higher which includes the normative database.
  • Action
    The firm is preparing a software "Roll Back" version of software to disable the NDB and other features, ensuring that this version will work properly. A customer notification letter is provided as well as a correction verification form, installation instructions and user manual. If there are any questions, please call 1-866-344-8948.

Device

Device Recall Optovue RTVue Optical Coherence Tomography with Normative Database
  • Model / Serial
    Serial Numbers from 10005 to 11805 (serial number are sequential)
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide
  • Product Description
    Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA || The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
  • Manufacturer
    Optovue Inc.

Manufacturer

Optovue Inc.
  • Manufacturer Address
    Optovue Inc., 45331 Northport Loop W, Fremont CA 94538-6417
  • Manufacturer Parent Company (2017)
    Optovue Inc.
  • Source
    USFDA