Z-0168-2018Class II

Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture...

Name: Z-0168-2018 Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-05-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-05-22 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to... on 2017-05-22. FDA classified it as Class II and gives the reason as "Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that...". 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-0168-2018
Classification: Class II
Status: Terminated
Initiated: 2017-05-22
Posted: 2017-11-21
Terminated: 2018-07-02
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 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 work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Customer Information Letter dated May 17, 2017. Customers Instructions: If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 448-6478.
Quantity in commerce: 2 units
Distribution: Distribution to MN
Product codes and lots: non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-21

Product code LLZ

K132532Class IISyngo.plaza Vb10aSiemens AG Healthcare / cleared 2013-12-09

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)