Elekta, Inc. is recalling 352 Leksell Gamma Knife radiosurgery systems, including the Perfexion, Icon, and Esprit models. The recall was initiated because the adapter on these units may not be properly aligned or locked into place. This equipment is used for delivering precise radiation doses to structures in the head, and a mechanical misalignment could affect treatment accuracy or patient safety. The affected units were distributed worldwide and across 36 U.S. states and Puerto Rico.
If the adapter is not correctly aligned or securely locked, it may lead to inaccurate radiation delivery during stereotactic surgery or potential mechanical failure during the procedure. This could result in incorrect dosing or injury to the patient.
Correction or repair of the adapter mechanism.
Leksell Gamma Knife radiosurgery system for head structures.
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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