Olympus Corporation of the Americas is recalling 55 units of the ShockPulse-SE Lithotripsy System with Generator due to a mis-wired internal component. This defect can cause electrical noise that interferes with the system's ultrasonic function, potentially leading to device failure or delays during surgical procedures. The recall affects specific serial numbers of the ShockPulse-SE Lithotripsy System reusable probes and generators used in medical facilities.
The improperly wired component creates electrical interference that may decrease the overall reliability of the surgical system, which can result in a delay of treatment for patients undergoing procedures to fragment kidney, ureter, or bladder stones.
System used for fragmentation of stones in the urinary tract. Expansion of previous action to include additional serial numbers.
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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