Skip to content
Recall Observatory FDA recall evidence

Device product

SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

Z-1644-2015

April 20, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 71101
Status
Terminated
Classification
Class II
Quantity
75
Official record key
device-enforcement:Z-1644-2015

Official wording

Reason: Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.

Code information: SOMATOM Emotion 6 (2007) - 10165888 with serial numbers: 29338 27232 27230 27231

Distribution pattern: Nationwide Distribution including Puerto Rico.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software bugs in VC20B SP0a or SP1 software versions may cause issues that could