Reported Jun 19, 2024 · Ongoing
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing…
Blue Belt Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Blue Belt Technologies, Inc · 2875 Railroad St · Pittsburgh, PA · 15201
Is this the product you have?
- 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 Notethe three product numbers cover the three different configurations in which the CORI Console is sold
- Lot codes and dates
- UDI-DI
(1) ROB10000t 00885556755068(2) ROB10024 00885556757420(3)
- ROB10197 00885556796849 Serial Numbers
1,270 of 1,270 codes
SN000001SN000048SN000095SN000142SN000189SN000236SN000002SN000049SN000100SN000143SN000190SN000237SN000003SN000050SN000101SN000144SN000191SN000238SN000004SN000051SN000102SN000145SN000192SN000239SN000005SN000052SN000103SN000146SN000193SN000240SN000006SN000053SN000096SN000147SN000194SN000241SN000007SN000054SN000097SN000148SN000195SN000242SN000008SN000055SN000098SN000149SN000196SN000243SN000009SN000056SN000099SN000150SN000197SN000244SN000010SN000057SN000104SN000151SN000198SN000245
- UDI-DI
- Amount recalled
- 916 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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