Blue Belt Technologies, Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing softwClass IIMay 7, 2024CORI Surgical System with Real Intelligence Software exhibit	CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) whi	Class IIDevices	May 7, 2024
CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013SClass IINov 13, 2023Possibility that the user is unable to resolve drill disconn	Possibility that the user is unable to resolve drill disconnection error messages.	Class IIDevices	Nov 13, 2023
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102Class IISep 7, 2023CORI software was missing a planning stage that appears in c	CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of t	Class IIDevices	Sep 7, 2023