MED-810A Zemits NDPrime Laser products
This recall is currently active, issued October 13, 2023. It was issued by Advance-Esthetic Llc.
- Company
- Advance-Esthetic Llc
- Recall Initiated
- October 9, 2023
- Posted
- October 13, 2023
- Recall Number
- Z-0095-2024
- Quantity
- 19
- Firm Location
- Fort Lauderdale, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standards and certification. This Recall provides correction by the firm regarding Zemits NdPrime Yag Tattoo Removal Laser. The product requires update or is missing the following in part: remote interlock connector, safety interlocks, manual reset mechanism, beam attenuator, tests for determination of compliance, certification, class IV designation and warning, labels, and labeling.
Distribution
US Nationwide Distribution
Lot / Code Info
Model MED-810A Zemits NDPrime Laser products
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Notification letters will be sent to affected customers identifying the reason for notification and action to be taken. The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For any queries or require further assistance, our customer support team is available at 888-999-3996 or customer-support@advance-esthetic.us.