Olympus Corporation of the Americas is recalling 1,532 units of Soltive Premium and Soltive Pro SuperPulsed Laser Systems because of a software translation error. On the system's screen, the term "Bladder Stone" was incorrectly translated into Spanish and Portuguese as "Kidney Stone" (Cálculo renal). No incidents or injuries have been reported, but the firm has initiated this voluntary recall to correct the display error.
The translation error could lead a medical professional to select the wrong setting, potentially delivering an incorrect or unintended amount of laser energy to the patient's anatomy during a procedure.
Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue; Recall #: Z-0134-2025.
Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue; Recall #: Z-0135-2025.
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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