medical Class II Updated 2021-12-01

Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash with software syngo.CT VB20 Model

Recalled Product

SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603

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: 73917 73531 73126 98623 73066 74909 73152 73760 98602 98603 73476 73726 73586 73937 98616 74206 73544 73648 74156 73636 74207 73813 74360 73054 74128 73427 98600 73622 73621 73424 73423 73493 73520 73718 73296 73471 73786 74374 98620 73831 74042 74191 74405 74117 74118 73673 73497 74929 73409 73935 73642 74240 73657 73090 73030 73013 73300 73499 73535 73655 73355 73036 73908 74978 73008 74391 74209 73490 73059 73758 73513 98632 98630 74094 74098 73895 73141 74262 74158 74153 74192 73670 73051 73360 74226 74297 74234 74364 73162 73683 74068 73320 73635 73405 73547 73931 73135 73818 73873 73266 73197 74511 73591 98642 73905 73225 73938 98605 73443 74922 73886 73413 73445 74129 73261 74093 74251 73348 73430 73574 74152
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