medical Class II Updated 2021-12-01

Siemens Medical Solutions USA, Inc recalls SOMATOM Drive with software syngo.CT VB20 Model #10431700

Recalled Product

SOMATOM Drive with software syngo.CT VB20 Model #10431700

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: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237
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