Olympus Corporation of the Americas has recalled 189 units of the SOLTIVE Pro SuperPulsed Laser System because the device's preset treatment parameters do not consistently match the instructions for use. This issue affects model numbers TFL-SLS and TFL-PLS, as well as their premium and standard laser module components. No injuries have been reported, but the manufacturer is initiating this voluntary recall to ensure the devices are used with correct settings. Healthcare facilities should stop using the affected systems and contact the manufacturer for a correction or replacement.
The laser system may not consistently use the treatment settings specified in its instructions, which could lead to incorrect energy delivery during surgical procedures like ureteroscopy. This inconsistency poses a risk of ineffective treatment or unintended tissue damage to the patient.
Recall covers all units. Includes laser module components TFL-CPLU and TFL-CSLU.
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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