medical Class II Updated 2021-01-20

Siemens Medical Solutions USA, Inc recalls SOMATOM Force, Definition AS, Definition Edge, Definition Fl

Recalled Product

SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus


Hazard / Issue

System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000) Siemens SOMATOM CT scanner systems with software syngo.CT VB20A_SP2.
View official government recall

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