Quantum Surgical has recalled two units of the EPIONE device v1.0.2, a stereotactic accessory used to assist doctors during CT-guided medical procedures. The company discovered that a central axis component inside the Needle Guide (product number 02-0027) is prone to rusting. This defect was identified through a firm-initiated voluntary recall involving units distributed specifically in Florida.
The presence of rust on the central axis of the needle guide could potentially contaminate the sterile field or interfere with the precision of the instrument during surgical procedures, posing a risk of infection or procedural complications for the patient.
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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.
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Sources: FDA iRES · Raw API Response
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