Events

Recall of Device Recall Image Consultant (IC) Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by R.O. Gulden & Co., 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
    54633
  • Event Risk Class
    Class 2
  • Event Number
    Z-1176-2010
  • Event Initiated Date
    2010-02-05
  • Event Date Posted
    2010-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88852
  • 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
    Device, storage, images, ophthalmic - Product Code NFF
  • Reason
    Software not validated; inaccurate results may occur.
  • Action
    On 2/5/10, the recalling firm issued letters via certified mail to its consignees informing them of the problem and to cease use of the software for diagnosis.

Device

Device Recall Image Consultant (IC) Software
  • Model / Serial
    product is not coded
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was shipped to eye doctors/clinics in AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, and WA.
  • Product Description
    Image Consultant (IC) Software
  • Manufacturer
    R.O. Gulden & Co., Inc.

Manufacturer

R.O. Gulden & Co., Inc.
  • Manufacturer Address
    R.O. Gulden & Co., Inc., 225 Cadwalader Ave, Elkins Park PA 19027-2020
  • Source
    USFDA