Z-2719-2015Class II

Syngo.plaza; picture archiving and communications system

Name: Z-2719-2015 Syngo.plaza; picture archiving and communications system
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-07-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-07-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display... on 2015-07-06. FDA classified it as Class II and gives the reason as "Potential issue leading to data loss and patient data mix-up". 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-2719-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-06
Posted: 2015-09-02
Terminated: 2017-01-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza; picture archiving and communications system Product Usage: 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: Potential issue leading to data loss and patient data mix-up
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Information letter, dated July 6, 2015, to customers The letter identified the affected product, problem and action to be taken. The letter informed cusotmers about the Hotfix software update that was being released.
Quantity in commerce: 37
Distribution: US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
Product codes and lots: Model Number of device 10592457 with serial numbers: Serial 100544 100499 100600 100571 100263 200308 200309 200310 200311 200312 200313 200314 200315 200316 200317 200318 200319 200320 200321 200322 200323 200324 100146 200277 100177 100138 100174 100491 100492 100596 100198 100181 200251 200252 100301 100302 100539

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2719-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2719-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02

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)