11

Jun

2024

FDA Reall: Software Error May Cause Surgical Delay due to Tracker Arrays Flickering

0

Company: Blue Belt Technologies, Inc
Date of Enforcement Report: 6/11/2024
Class II

PRODUCT

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.

Recall Number:

Z-2135-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Blue Belt Technologies, Inc

VOLUME OF PRODUCT IN COMMERCE:

916 units

DISTRIBUTION:

Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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