Z-0862-2016Class II

Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process...

Name: Z-0862-2016 Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-12-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-12-22 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and... on 2015-12-22. FDA classified it as Class II and gives the reason as "Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading...". 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-0862-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-22
Posted: 2016-02-23
Terminated: 2017-09-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Voluntary Correction and Removal Action letter dated December 30, 2015. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that a software update VB10A_HF01/06 is being released simulataneously to eliminate the issue. Customers with questions were instructed to call 1-888-826-9702.
Quantity in commerce: 68
Distribution: Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI
Product codes and lots: Device model numbers: 10863171, 10863172, 10863173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0862-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0862-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23

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)