Z-0826-2016Class II

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance...

Name: Z-0826-2016 software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-01-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-01-29 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation... on 2016-01-29. FDA classified it as Class II and gives the reason as "Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0826-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Posted: 2016-02-19
Terminated: 2017-02-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: [email protected].
Quantity in commerce: 151
Distribution: US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
Product codes and lots: For model #10091673

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0826-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0826-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-19

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)