Events

Recall of SPECULAR MICROSCOPE CEM530

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
    74900
  • Event Risk Class
    Class 2
  • Event Number
    Z-2711-2016
  • Event Initiated Date
    2016-08-08
  • Event Date Posted
    2016-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148728
  • 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
    Microscope, specular - Product Code NQE
  • Reason
    Software version 1.08 and 1.09 for the specular microscope cem 530 included a change of analysis results feature that was not reviewed and approved by the fda.
  • Action
    The firm, Nidek, sent a Dear Doctor letters entitled "RECALL NOTIFICATION" dated August 15, 2016 to affected sites by Federal Express. The letter informs users of the issue and stated that Nidek field service representatives will visit to install updated software. If you have any questions, please call Customer Service at 1-800-722-0219; Monday-Friday 8am to 5pm PST or email: cem530update@noritsuservice.com.

Device

SPECULAR MICROSCOPE CEM530
  • Model / Serial
    Microscopes with serial numbers: 120004,120005, 120006, 120007, 120009, 120010, 120011,120012, 120013, 120014, 0120016, 120019, 120021, 120023, 120024, 120026, 120030, 120036, 0120038, 120039, 120040, 120042, 120044,120045, 120046, 120047, 120048, 120049, 120050.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: TX, KS, FL, NV, CA, PA, KY, OR, TN, AL, VA, MO, OK, CT, NY. LA, NM, and IN.
  • Product Description
    SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. || Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured || images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
  • 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