Blue Belt's CORI Surgical System with Real Intelligence Software has an increased Marker Registration Error that may cause tracker arrays to flicker on screen during surgery, potentially delaying procedures. Affected units include specific product models and serial numbers listed in the recall notice.
CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay
Blue Belt's CORI Surgical System software may cause tracker arrays to flicker on screen during surgery, which could lead to surgical delays. This recall affects specific product models and serial numbers listed in the official notice.
The CORI Surgical System software has an increased Marker Registration Error (MRE) that can cause tracker arrays to flicker on the surgical display. This flickering may lead to delays in surgical procedures as the system struggles to accurately track anatomical structures during orthopedic surgeries.
Surgeons and medical professionals using Blue Belt's CORI Surgical System with Real Intelligence Software are most at risk. Affected units include specific product models and serial numbers listed in the recall notice.
Check for the product models: CORI Starter Kit (ROB10000), Real Intelligence CORI (ROB10024), or CORI STARTER KIT - UNIVERSAL (ROB10197). Affected units have specific serial numbers listed in the recall notice.
Identify your CORI Surgical System model and serial number to confirm if it's affected.
Reach out to Blue Belt Technologies, Inc. for further assistance with the recall.
The CORI Surgical System is a software-defined spatial boundaries tool designed to assist surgeons in providing orientation and reference information during orthopedic procedures.
Check the product model (ROB10000, ROB10024, or ROB10197) and the serial number listed in the recall notice.
Contact Blue Belt Technologies, Inc. for further assistance with the recall.
We’ve drafted a message you can send Blue Belt to request your refund or repair — edit it as you like.
Subject: Recall Z-2135-2024 — Blue Belt Blue Belt Hello, I own a Blue Belt that is covered by recall Z-2135-2024 from Blue Belt. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
