Skip to content
Recall Observatory FDA recall evidence

Device product

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. 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), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20

Z-0406-2020

October 07, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 84110
Status
Terminated
Classification
Class II
Quantity
305 units
Official record key
device-enforcement:Z-0406-2020

Official wording

Reason: Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

Code information: Software versions syngo CT VB20

Distribution pattern: Nationwide

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software issue