CORI Surgical System Software Error Causes Tracking Array Flickering
The CORI Starter Kit surgical system may experience display flickering from a software tracking error, potentially causing surgical delays during orthopedic procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a software malfunction affecting surgical guidance accuracy. No reported illnesses, injuries, or deaths have been documented. The hazard is operational—potential surgical delay and display malfunction—rather than direct patient harm, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Blue Belt Technologies is recalling certain CORI Starter Kit surgical systems and configurations (product numbers ROB10000, ROB10024, ROB10197) due to a software issue identified in the Real Intelligence CORI system. The device exhibits an increased Marker Registration Error that may cause tracker arrays to flicker on the system's display during orthopedic surgical procedures.
The flickering display may cause surgical delay, which could affect the timing and accuracy of guidance information during orthopedic procedures. The affected systems (916 units) have been distributed nationwide and internationally to 39 countries.
Surgical facilities and healthcare providers using affected units should contact Blue Belt Technologies for remediation instructions. Surgeons using affected systems should monitor for display flickering and understand that surgical delays may occur until the software issue is resolved.
The recalled product
- 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…
- Manufacturer
- Blue Belt Technologies, Inc
- Affected units
- 916
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: (1) ROB10000t 00885556755068
- (2) ROB10024 00885556757420
Distribution
Distributed nationwide across the United States.
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