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Recall Observatory FDA recall evidence

Device product

SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

Z-2273-2019

July 03, 2019

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 83377
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2273-2019

Official wording

Reason: Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

Code information: Serial Numbers: 122022 122020 122008 122036 122029 122044 122037 122009 122038 122035 122041 122011 122034 122004

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issues impacting systems utilizing syngo.CT software version VB10A which may result in