Z-1533-2017Class II

Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and...

Name: Z-1533-2017 Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-02-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-02-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display... on 2017-02-20. FDA classified it as Class II and gives the reason as "Software updates". 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-1533-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-20
Posted: 2017-03-10
Terminated: 2017-08-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is 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. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software updates
Root cause tag: software
FDA root cause: Software design
Action: Siemens mailed a notification letter dated February 21, 2017 to affected customers to inform them of the software updates that were now available to address several issues. Customers were advised to follow the instructions in the notice and where necessary promptly notify and instruct all their staff at their organization who have to be aware of the problem. Customers were also instructed to forward the information to new owners where possible. For questions regarding this recall call 610-219-4834.
Quantity in commerce: 13 systems
Distribution: Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA
Product codes and lots: Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1533-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1533-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-22

Product code LLZ

K093612Class IISyngo.plazaSiemens AG Medical Solutions / cleared 2010-03-04

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)