Blue Belt Technologies

3 recalls •

• Categories: Infusion Pumps, Other Medical Devices, Implants & Prosthetics

CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold

Class I - Dangerous

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

May 7, 2024 Infusion Pumps Nationwide View Details →

CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S

Class I - Dangerous

Possibility that the user is unable to resolve drill disconnection error messages.

Nov 13, 2023 Other Medical Devices Nationwide View Details →

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Class I - Dangerous

CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis

Sep 7, 2023 Implants & Prosthetics Nationwide View Details →