Z-0495-2018Class II

Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers...

Name: Z-0495-2018 Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers...
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-08-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-08-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture... on 2017-08-18. FDA classified it as Class II and gives the reason as "Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to...". 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-0495-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-18
Posted: 2018-01-31
Terminated: 2018-08-30
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device 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 update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.
Root cause tag: software
FDA root cause: Software design
Action: Siemens released a software update VB20A_HF04 and a Customer Information Letter was sent with Update Instruction SY010/17/P. Service reports for the affected sites will be monitored to ensure the recall was effective. For further questions, please call (610) 219-6461.
Quantity in commerce: 47
Distribution: USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.
Product codes and lots: Syngo.plaza with software version VB20A; Model numbers: 10863171, 10863172, 10863173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0495-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0495-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-31

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)