Events

Recall of The Enfant Evoked Response Photic Stimulator.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diopsys 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
    29999
  • Event Risk Class
    Class 3
  • Event Number
    Z-0186-05
  • Event Initiated Date
    2004-09-15
  • Event Date Posted
    2004-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34983
  • 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
    Stimulator, Photic, Evoked Response - Product Code GWE
  • Reason
    The firm established no medical device quality system, no established quality plan and no established quality procedures.
  • Action
    The firm sent out a recall letter to their customers on 09/14/2004 stating that a field correction will be conducted at each site.

Device

The Enfant Evoked Response Photic Stimulator.
  • Model / Serial
    No manufacturing codes are affixed to the units. The firm maintains some in-house identification numbers which are: 10001; 10003; 10004; 10005; 10006; 10007; 10008; 10009; 100010; 100011; 100012; 100013; 100014; 100015; 100016.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributes the Enfant VEP medical device systems in 3 states, NY, NJ, and CT at the current time. There is no international distribution at this time. There are no Government, or military accounts. The rental/leasing of the units are direct. No contracts have been established. There are 17 domestic consignees.
  • Product Description
    The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.
  • Manufacturer
    Diopsys Inc

Manufacturer

Diopsys Inc
  • Manufacturer Address
    Diopsys Inc, 355 Main St, Metuchen NJ 08840
  • Source
    USFDA