Z-1116-2017Class II

Syngo.plaza, picture archiving and communications system

Name: Z-1116-2017 Syngo.plaza, picture archiving and communications system
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-01-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-01-11 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza, picture archiving and communications system on 2017-01-11. FDA classified it as Class II and gives the reason as "Software update for improvements and to resolve several issues". 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-1116-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Posted: 2017-01-31
Terminated: 2017-11-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza, picture archiving and communications system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software update for improvements and to resolve several issues
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Siemens mailed a Customer Letter to affected customers on 01/13/2017 to provide information about the latest software change that is now available to address several issues.
Quantity in commerce: 62 systems
Distribution: Distributed throughout the United States.
Product codes and lots: Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1116-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1116-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-31

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)