Olympus Corporation of the Americas has recalled 440 SOLTIVE Premium and SOLTIVE Pro SuperPulsed Laser Systems due to a defect in the 24V power supply module. This defect can cause the laser system to stop working during medical procedures, and in some cases, may cause the device to emit smoke or a burning smell. While the issue is designed to be contained within the internal enclosure and is self-extinguishing, it can lead to procedure delays or hardware failure.
The power supply defect may cause the system to become inoperable during use or result in smoke and burning odors within the clinical environment. This poses a risk of procedure interruption or potential respiratory irritation if smoke is released, although the internal design is intended to contain and extinguish any combustion.
Quantity affected: 408 units. Device assembly for tissue vaporization/ablation.
Quantity affected: 32 units. Device assembly for tissue vaporization/ablation.
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
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