Events

Recall of Device Recall MC500 Multicolor Laser Photocoagulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nidek 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
    69531
  • Event Risk Class
    Class 2
  • Event Number
    Z-0222-2015
  • Event Initiated Date
    2013-05-24
  • Event Date Posted
    2014-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130878
  • 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
    Laser, ophthalmic - Product Code HQF
  • Reason
    Retrospective review found that a engineering change order initiated in may 2013 for a memory function problem was not reported as required.
  • Action
    Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.

Device

Device Recall MC500 Multicolor Laser Photocoagulator
  • Model / Serial
    MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the states of: CA, NE, and NY.
  • Product Description
    MC-500 Multicolor Laser Photocoagulator using software version 2.20. || Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
  • Manufacturer
    Nidek Inc

Manufacturer

Nidek Inc
  • Manufacturer Address
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Manufacturer Parent Company (2017)
    Nidek Co. Ltd.
  • Source
    USFDA