medical Class II Updated 2021-12-01

Siemens Medical Solutions USA, Inc recalls SOMATOM Edge Plus with software syngo.CT VB20 Model #102670

Recalled Product

SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000

Hazard / Issue

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004
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