Blue Belt Technologies, Inc: CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and

Hazard

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

Details from the source

Reason for recall: 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 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 Quantity: 916 units Lot/code info: UDI-DI: (1) ROB10000t 00885556755068; (2) ROB10024 00885556757420; (3) ROB10197 00885556796849 Serial Numbers: SN000001 SN000048 SN000095 SN000142 SN000189 SN000236 SN000002 SN000049 SN000100 SN000143 SN000190 SN000237 SN000003 SN000050 SN000101 SN000144 SN000191 SN000238 SN000004 SN000051 SN000102 SN000145 SN000192 SN000239 SN000005 SN000052 SN000103 SN000146 SN000193 SN000240 SN000006 SN000053 SN000096 SN000147 SN000194 SN000241 SN000007 SN000054 SN000097 SN000148 SN000195 SN000242 SN000008 SN000055 SN000098 SN000149 SN000196 SN000243 SN000009 SN000056 SN000099 SN000150 SN000197 SN000244 SN000010 SN000057 SN000104 SN000151 SN000198 SN000245 SN000011 SN000058 SN000105 SN000152 SN000199 SN000246 SN000012 SN000059 SN000106 SN000153 SN000200 SN000247 SN000013 SN000060 SN000107 SN000154 SN000201 SN000248 SN000014 SN000061 SN000108 SN000155 SN000202 SN000249 SN000015 SN000062 SN000109 SN000156 SN000203 SN000250 SN000016 SN000063 SN000110 SN000157 SN000204 SN000251 SN000017 SN000064 SN000111 SN000158 SN000205 SN000252 SN000018 SN000065 SN000112 SN000159 SN000206 SN000253 SN000019 SN000066 SN000113 SN000160 SN000207 SN000254 SN000020 SN000067 SN000114 SN000161 SN000208 SN000255 SN000021 SN000068 SN000115 SN000162 SN000209 SN000256 SN000022 SN000069 SN000116 SN000163 SN000210 SN000257 SN000023 SN000070 SN000117 SN000164 SN000211 SN000258 SN000024 SN000071 SN000118 SN000165 SN000212 SN000259 SN000025 SN000072 SN000119 SN000166 SN000213 SN000260 SN000026 SN000073 SN000120 SN000167 SN0

UPC codes

00885556755068, 00885556757420, 00885556796849

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.