Somatom Emotion 16

• 4 recalls, same reason

  • Terminated Z-1453-2018 FDA Class II ·initiated 15 Feb 2018
  • Terminated Z-1452-2018 FDA Class II ·initiated 15 Feb 2018
  • Terminated Z-1454-2018 FDA Class II ·initiated 15 Feb 2018
  • Terminated Z-1459-2018 FDA Class II ·initiated 15 Feb 2018

  to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

• • Terminated Z-1301-2016 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-1721-2014 FDA Class II ·initiated 21 Mar 2014

  The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

• • Terminated Z-2453-2008 FDA Unclassified (pre-2012) ·initiated 5 Aug 2008

  Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.

• • Terminated Z-0793-06 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.

1. 1 Mar 2005 Cleared FDA 510(k) K050297
2. 9 Mar 2006 Recall initiated FDA recalls Z-0793-06
3. 5 Aug 2008 Recall initiated FDA recalls Z-2453-2008
4. 21 Mar 2014 Recall initiated FDA recalls Z-1721-2014
5. 15 Feb 2016 Recall initiated FDA recalls Z-1301-2016
6. 15 Feb 2018 Recall initiated FDA recalls Z-1453-2018
7. 15 Feb 2018 Recall initiated FDA recalls Z-1452-2018
8. 15 Feb 2018 Recall initiated FDA recalls Z-1454-2018
9. 15 Feb 2018 Recall initiated FDA recalls Z-1459-2018

510(k) Number

K050297 ↗

FDA product code

JAK

Device class

Class II

Regulation

21 CFR Part 892.1750

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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• SCENARIA View Phase 5.0 by FUJIFILM CORPORATION
• Photonova Spectra 5590000-50 by GE Medical Systems, L.L.C.

• Symbia Intevo Bold combination

  Class IIb

  CE/MDR

• Biograph Vision 600 Combination

  Class IIb

  CE/MDR

• CS-20-1 Uniform Phantom Combi

  Class IIb

  CE/MDR

• Biograph Vision Quadra Combination

  Class IIb

  CE/MDR

See all devices from Siemens Medical Solutions USA, Inc. →