Z-1354-2015Class II

Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report...

Name: Z-1354-2015 Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-02-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-02-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital... on 2015-02-18. FDA classified it as Class II and gives the reason as "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farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain...". 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-1354-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-18
Posted: 2015-03-30
Terminated: 2016-08-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
Root cause tag: software
FDA root cause: Software design
Action: Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS.
Quantity in commerce: 4
Distribution: US Distribution: MA, WI, FL
Product codes and lots: Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1354-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1354-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-30

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)