Quantum Surgical SAS is recalling four units of the EPIONE Robotic Surgical Accessory (Model 30-0001) due to a software defect in version 1.0.6.1. The bug may cause the robotic arm to guide surgical instruments incorrectly, deviating from the path specifically planned by the physician. This recall affects units distributed to hospitals in Florida, Illinois, Indiana, and Texas; no injuries have been reported to date.
The software bug can cause the robotic arm to move surgical needles or probes away from the intended target during abdominal procedures. This misguidance could lead to internal organ damage or an unsuccessful medical procedure.
Stereotactic accessory used for CT-guided percutaneous ablation procedures in the abdomen.
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.
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Sources: FDA iRES · Raw API Response
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