Events

Recall of Device Recall EZ Illuminations Northern Lights EZ Illuminations Galaxy

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SANTA JOY ORNAMENT & GIFTWARE CO.

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
    78975
  • Event Risk Class
    Class 2
  • Event Number
    Z-1884-2018
  • Event Initiated Date
    2017-11-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160993
  • 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
    Low-power laser light show projector - Product Code RDZ
  • Reason
    It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for class iiia products.
  • Action
    The Firm will bring the device into compliance by : 1. Santa Joy Ornament (SJO) will provide a full refund in exchange for the return of the models listed above. Returned products will be destroyed. 2. SJO has purchased optical measurement equipment and intends to measure the output of each laser product and ensure all laser products comply with applicable performance standards before shipment. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. For further questions, please call (410) 540-9840.

Device

Device Recall EZ Illuminations Northern Lights EZ Illuminations Galaxy
  • Model / Serial
    Model No: EZ-Illuminations Galaxy , EZ-Illuminations Northern Lights
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    USA (nationwide) distribution
  • Product Description
    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy || Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
  • Manufacturer
    SANTA JOY ORNAMENT & GIFTWARE CO

Manufacturer

SANTA JOY ORNAMENT & GIFTWARE CO