Z-1027-2015Class II

Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process...

Name: Z-1027-2015 Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-01-13
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-01-13 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and... on 2015-01-13. FDA classified it as Class II and gives the reason as "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...". 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-1027-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-01-28
Terminated: 2017-02-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza: 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: 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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Siemens sent a Safety Advisory Notice dated January 13, 2015, to all affected customers. The Safety Notice identified the product, the problem, and the action to be taken. Siemens recommended checking patient data in the event of a system crash and advised customers that a software update is planned for mid-2015 that will resolve the issue. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 50
Distribution: Nationwide Distribution
Product codes and lots: Model Numbers: 10592457, 10863171, 10863173, 10863172; with serial numbers: Serial 100544 100262 100198 100258 200211 100135 100133 100213 100031 100084 100233 100140 200308 100245 100314 100139 100177 100197 100170 100025 100174 100186 100033 100306 100232 100185 100256 100199 100188 100257 100198 100226 100198 100228 100181 100029 100253 100301 100203 100132 100139 100247 100215 100230 100221 100146 100207 100212 100539 100206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1027-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1027-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-28

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)