Blue Belt Technologies, Inc.
2875 Railroad Street, Pittsburgh, PA, US
Registered product codes
11 product codes
Recent MDR events
13 on file
- REAL INTELLIGENCE CORIFeb 19, 2024Injury1020279-2024-00393
- REAL INTELLIGENCE CORIJan 8, 2024Injury1020279-2024-00051
- NAVIOJul 11, 2017Malfunction6701382
- NAVIO SURGICAL SYSTEMApr 21, 2017Injury3010266064-2017-00010
- NAVIO SURGICAL SYSTEMApr 18, 2017Injury3010266064-2017-00004
- NAVIO SURGICAL SYSTEMApr 18, 2017Injury3010266064-2017-00005
- NAVIO SURGICAL SYSTEMApr 18, 2017Injury3010266064-2017-00007
- NAVIO SURGICAL SYSTEMApr 18, 2017Injury3010266064-2017-00006
- NAVIO SURGICAL SYSTEMApr 18, 2017Injury3010266064-2017-00008
- NAVIO SURGICAL SYSTEMApr 18, 2017Injury3010266064-2017-00009
Recalls
3 on file
- Open, ClassifiedJun 11, 2024
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
View FDA record ↗ - Open, ClassifiedJan 11, 2024
Possibility that the user is unable to resolve drill disconnection error messages.
View FDA record ↗ - Open, ClassifiedOct 5, 2023
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
View FDA record ↗
Compliance history
Matched by FEI 3016090213.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.