Events

Recall of Device Recall Retcam3 & Retcam Shuttle with version

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Clarity Medical Systems 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
    61180
  • Event Risk Class
    Class 2
  • Event Number
    Z-1099-2012
  • Event Initiated Date
    2012-02-02
  • Event Date Posted
    2012-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107470
  • 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
    Camera, ophthalmic, Ac-powered - Product Code HKI
  • Reason
    Still images extracted from video recordings may be mislabeled as to right and left eye.
  • Action
    Clarity Medical Systems, Inc. sent a Safety Alert letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following : 1. Do not use the video mode until the software has been updated. 2. Install the software update using the enclosed CD. The instructions for installation are also enclosed. This software update will correct the anomaly. 3. If you have extracted still images from video recordings, review all potentially affected patient files to determine if any right eye images are mislabeled as left eye images and/or left eye images are mislabeled as right eye images. If any images are mislabeled, make the appropriate corrections in the annotation section of the affected file. Consider whether there is any diagnostic impact or need to re-irnage the patient. We apologize for the inconvenience. If you have questions or concerns, please contact Clarity at 800-215-6005.

Device

Device Recall Retcam3 & Retcam Shuttle with version
  • Model / Serial
    Model number RC3, part number 21-100500; Model number RCS, part number 20-000300.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of TN, MO, TX, FL, NJ and Puerto Rico and countries of Italy, Portugal, Czech Republic, Thailand, Chile, Oman, Hong Kong, Russia, Philippines, Sweden, Finland, Ecuador, Australia and Canada.
  • Product Description
    Retcam3 & Retcam Shuttle with version 6.0 software. || Clarity Medical Systems, Inc. || 5775 W. Las Positas Blvd, Suite 200 || Pleasanton, CA 94588 || General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
  • Manufacturer
    Clarity Medical Systems Inc

Manufacturer

Clarity Medical Systems Inc
  • Manufacturer Address
    Clarity Medical Systems Inc, 5775 W Las Positas Blvd, Pleasanton CA 94588
  • Manufacturer Parent Company (2017)
    Natus Medical Incorporated
  • Source
    USFDA