Somatom Definition Edge

• • Terminated Z-2269-2019 FDA Class II ·initiated 3 Jul 2019

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

• • Terminated Z-1521-2016 FDA Class II ·initiated 2 Mar 2016

  Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.

• • Terminated Z-0907-2014 FDA Class II ·initiated 15 Nov 2013

  During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B.

510(k) Number

K120579 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DynaCT

  Class II

  FDA 510(k) K042646 Active Cleared 19 Oct 2004

• Omnia X/Xs Ultrasound System

  Class II

  FDA 510(k) K020353 Active Cleared 13 Feb 2002

• Somatom Project P30L

  Class II

  FDA 510(k) K040577 Active Cleared 22 Mar 2004

• 6 Channel Body Coil

  Class II

  FDA 510(k) K023571 Active Cleared 20 Nov 2002

• Somatom Spirit

  Class II

  FDA 510(k) K042328 Active Cleared 14 Sep 2004

• Somatom P30 CT Systems

  Class II

  FDA 510(k) K013522 Active Cleared 7 Nov 2001

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