Events

Recall of Device Recall Sunnex

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunnex 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
    38075
  • Event Risk Class
    Class 2
  • Event Number
    Z-1100-2007
  • Event Initiated Date
    2007-02-13
  • Event Date Posted
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52905
  • 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
    Medical Examination Light - Product Code FTA
  • Reason
    Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
  • Action
    Sunnex notifiied distributors by letter March 9, 2007. Sunnex is providing replacement product to end users

Device

Device Recall Sunnex
  • Model / Serial
    Units manufactured between May 15, 2006 through October 1, 2006
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile).
  • Manufacturer
    Sunnex Inc.

Manufacturer

Sunnex Inc.
  • Manufacturer Address
    Sunnex Inc., 3 Huron Dr, Natick MA 01760-1314
  • Source
    USFDA