MED-810A Zemits NDPrime Laser products recall: Labeling Error
MED-810A Zemits NDPrime Laser products
Why was MED-810A Zemits NDPrime Laser products recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model MED-810A Zemits NDPrime Laser products
- Product
- MED-810A Zemits NDPrime Laser products
- Recalling firm
- Advance-Esthetic LLC
- Quantity
- 19
- Distribution
- US Nationwide Distribution
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)