Syngo Imaging Xs

• • Terminated Z-0550-2016 FDA Class II ·initiated 17 Nov 2015

  For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo Imaging XS printer configuration file.

• • Terminated Z-0576-2015 FDA Class II ·initiated 11 Nov 2014

  Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of printer and the syngo.plaza printer configuration file. Printouts in anatomical size are not correct and may influence diagnostic decisions and/or therapy.

• • Terminated Z-2111-2014 FDA Class II ·initiated 30 Jun 2014

  Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest, Pixel Lens, Edge enhancement and Histograms. This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel d

• • Terminated Z-2264-2012 FDA Class II ·initiated 18 Jul 2012

  There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".

• • Terminated Z-1064-2012 FDA Not yet classified ·initiated 26 Jan 2012

  In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisor

• • Terminated Z-0514-2012 FDA Unclassified (pre-2012) ·initiated 20 Sep 2011

  Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system.

• • Terminated Z-0515-2012 FDA Unclassified (pre-2012) ·initiated 19 Sep 2011

  Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series.

• • Terminated Z-1892-2010 FDA Unclassified (pre-2012) ·initiated 6 Apr 2010

  Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs.

• • Terminated Z-1423-2010 FDA Unclassified (pre-2012) ·initiated 16 Feb 2010

  images can be overwritten

• • Terminated Z-0174-2010 FDA Unclassified (pre-2012) ·initiated 30 Sep 2009

  Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.

• 2 recalls, same reason

  • Terminated Z-0271-2010 FDA Unclassified (pre-2012) ·initiated 29 Sep 2009
  • Terminated Z-0270-2010 FDA Unclassified (pre-2012) ·initiated 29 Sep 2009

  Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.

510(k) Number

K082430 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Syngo.CT Vascular Analysis

  Class II

  FDA 510(k) K112020 Active Cleared 18 Aug 2011

• Acuson SC2000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K142628 Active Cleared 10 Oct 2014

• Syngo.VIA

  Class II

  FDA 510(k) K123920 Active Cleared 18 Jan 2013

• Syngo.plaza

  Class II

  FDA 510(k) K093612 Active Cleared 4 Mar 2010

• Syngo Dynamics Version 7.0

  Class II

  FDA 510(k) K081018 Active Cleared 25 Apr 2008

• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

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