Inova Lasers LLC recalls Class IV New Era medical laser device

Recall date

January 29, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0440-2021

FDA classification

Class II

Brand / firm

Inova Lasers LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.

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

What was recalled

Class IV New Era medical laser device