Somatom Force

• • Terminated Z-0771-2021 FDA Class II ·initiated 24 Nov 2020

  System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan

• • Terminated Z-3025-2020 FDA Class II ·initiated 22 Jun 2020

  Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

• • Terminated Z-0406-2020 FDA Class II ·initiated 7 Oct 2019

  Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

• • Terminated Z-2274-2019 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-0692-2017 FDA Class II ·initiated 20 Oct 2016

  Siemens is providing software update version VA50A_SP3 to address the software bugs that were identified through normal field monitoring and the Global Complaint Handling Process. Correction for the problems are as follows: 1. Correction to volumetric misrepresentations of high contrast objects when using ADMIRE. 2. Correction to highly sporadic scan aborts due to temporarily tube currents at 0mA. 3. Correction to missing Microsoft Hotfixes (MS16-001, MS15-135, MS15-088, MS15-048). 4. Correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. Correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. Correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. Correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.

• • Terminated Z-1558-2016 FDA Class II ·initiated 1 Apr 2016

  The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.

• • Terminated Z-0107-2016 FDA Class II ·initiated 18 Aug 2015

  Software and firmware bugs

• • Terminated Z-1267-2015 FDA Class II ·initiated 6 Feb 2015

  Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.

• • Terminated Z-0971-2015 FDA Class II ·initiated 3 Dec 2014

  Artifacts are found in acquired imaging on the SOMATOM Force.

1. 17 Apr 2014 Cleared FDA 510(k) K133589
2. 3 Dec 2014 Recall initiated FDA recalls Z-0971-2015
3. 6 Feb 2015 Recall initiated FDA recalls Z-1267-2015
4. 18 Aug 2015 Recall initiated FDA recalls Z-0107-2016
5. 1 Apr 2016 Recall initiated FDA recalls Z-1558-2016
6. 20 Oct 2016 Recall initiated FDA recalls Z-0692-2017
7. 3 Jul 2019 Recall initiated FDA recalls Z-2274-2019
8. 7 Oct 2019 Recall initiated FDA recalls Z-0406-2020
9. 22 Jun 2020 Recall initiated FDA recalls Z-3025-2020
10. 24 Nov 2020 Recall initiated FDA recalls Z-0771-2021

510(k) Number

K133589 ↗

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).

• SYNGO.CT NEURO PERFUSION by Siemens Medical Systems USA, Inc.
• AQUILION ONE VISION, V4.90 by Toshiba America Medical Systems, In.C
• EXEL 2002 & 2002FS CT SCANNER by Elscint, Inc.
• PERCUNAV by Philips Health Care
• IG 4 IMAGE GUIDED SYSTEM by VERAN MEDICAL TECHNOLOGIES INC.
• SMART BREATH RESPIRATORY COMPENSATION OPTION by GE MEDICAL SYSTEMS, INC.
• RTR-2000/RTR-4000 by Terarecon Inc.
• OMNIMEDICAL 400L by Omnimedical Services, Inc.
• MODEL TSX-301B AQUILION CT SYSTEM by Toshiba America Medical Systems, In.C
• SYNERVIEW MODEL 6545 by Philips Medical Systems (Cleveland), Inc.

• 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. →