Blue Belt Technologies is recalling 916 units of the CORI Surgical System, including the CORI Starter Kit and Real Intelligence CORI software. The affected systems exhibit an increased Marker Registration Error (MRE) which can cause the tracker arrays on the surgical screen to flicker or disappear during use. This defect can lead to significant delays during orthopedic procedures while surgeons attempt to resolve the display issues. The recalled units were distributed nationwide and internationally with specific serial numbers ranging from SN000001 to SN001404.
The software error causes a loss of visual orientation data during surgery, potentially leading to surgical delays or the need for manual intervention if the tracking system fails to stabilize. While no specific injuries were reported in this data, display flickering during critical orthopedic maneuvers poses a moderate risk to the precision and timing of the procedure.
Manufacturer initiated contact via letter
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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