Class IV New Era medical laser device

Company

Inova Lasers Llc

Recall Initiated

January 29, 2020

Recall Number

Z-0440-2021

Quantity

8 units

Firm Location

New York, NY

Reason for Recall

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.

Distribution

US Nationwide Distribution

Lot / Code Info

New Era laser units

Root Cause

Radiation Control for Health and Safety Act

Action Taken

Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.