IDS LTD has recalled 23 units of the Smaxel Fractional CO2 Laser, which is a Class IV medical laser system. This recall was issued because the devices were distributed without a required Certification label and lacked adequate instructions for safe operation. While no incidents or injuries have been reported, these omissions mean the devices do not meet safety compliance standards for high-powered lasers.
The absence of safety labels and operational instructions for a high-powered Class IV laser increases the risk of accidental exposure or improper handling. Without clear guidance on safe use, operators and patients could be at risk for serious injury, including burns or eye damage.
Code information is currently listed as unknown in the official enforcement report.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.