Syngo.plaza

• • Terminated Z-1533-2017 FDA Class II ·initiated 20 Feb 2017

  Software updates

• • Terminated Z-1116-2017 FDA Class II ·initiated 11 Jan 2017

  Software update for improvements and to resolve several issues

• • Terminated Z-2891-2016 FDA Class II ·initiated 6 Sep 2016

  Software upgrade to eliminate several issues

• • Terminated Z-2793-2016 FDA Class II ·initiated 2 Aug 2016 ·on shared 510(k) K093612

  Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

• • Terminated Z-2088-2016 FDA Class II ·initiated 9 May 2016

  Software error in previous software versions in which two references for the same image may exist in the database.

• • Terminated Z-0862-2016 FDA Class II ·initiated 22 Dec 2015

  Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.

• • Terminated Z-2719-2015 FDA Class II ·initiated 6 Jul 2015

  Potential issue leading to data loss and patient data mix-up

• • Terminated Z-1354-2015 FDA Class II ·initiated 18 Feb 2015

  Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

• • Terminated Z-1027-2015 FDA Class II ·initiated 13 Jan 2015

  In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk and might get lost.

• • 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-1975-2013 FDA Class II ·initiated 4 Mar 2013

  Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

• • Terminated Z-0465-2013 FDA Class II ·initiated 20 Jun 2012

  Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could

• • Terminated Z-0048-2013 FDA Class II ·initiated 6 Jun 2012

  Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

• • Terminated Z-1127-2012 FDA Not yet classified ·initiated 20 Jan 2012

  There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this can happen when an archive server with a USB dongle-based license is enabled with auto archiving. If the disk fill level is reached which triggers auto deleti

• • Terminated Z-0522-2012 FDA Unclassified (pre-2012) ·initiated 21 Sep 2011

  Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more images of that study may exist which are not shown in the syngo.plaza viewer.

• • Terminated Z-0271-2014 FDA Class II ·initiated 8 Aug 2011

  The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K093612 ↗

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 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

• Syngo Perfusion-CT

  Class II

  FDA 510(k) K033832 Active Cleared 23 Dec 2003

See all devices from Siemens Medi Cal Solutions, Inc. →