Somatom Project P30L

• • Terminated Z-1307-2016 FDA Class II ·initiated 15 Feb 2016

  Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".

• • Terminated Z-0796-06 FDA Unclassified (pre-2012) ·initiated 9 Mar 2006

  When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

510(k) Number

K040577 ↗

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

• 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

• Somatom Definition Edge

  Class II

  FDA 510(k) K120579 Active Cleared 23 May 2012

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