Medical device recalls Moderate risk

SANTA JOY ORNAMENT & GIFTWARE CO recalls Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that…

Recall date
November 21, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1884-2018
FDA classification
Class II
Brand / firm
SANTA JOY ORNAMENT & GIFTWARE CO
Sold / distributed
USA (nationwide) distribution

Why it was recalled

It was discovered that the product units it imported may, at peak levels, emit radiation that exceeds the federal standard for Class IIIa products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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