Elekta, Inc. is recalling 768 units of the Leksell Vantage Arc System and its components because the locking mechanisms may not properly secure to the Arc system. This defect can cause the coordinates to shift during medical procedures, potentially leading to inaccurate treatment delivery. Affected components include 364 Left Z-Slides and 364 Right Z-Slides with specific serial numbers.
If the locking mechanism fails during a procedure, the system coordinates can shift unexpectedly. This poses a risk of serious injury if medical instruments or treatments are misdirected due to inaccurate positioning.
Serial numbers 00001 to 00625 for Left Z-Slide; serial numbers 00001 to 00675 for Right Z-Slide.
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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