Z-2088-2016Class II

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173

Name: Z-2088-2016 Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-05-09
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-05-09 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173 on 2016-05-09. FDA classified it as Class II and gives the reason as "Software error in previous software versions in which two references for the same image may exist in the database". 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-2088-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Posted: 2016-06-29
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Software error in previous software versions in which two references for the same image may exist in the database.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Customer Information letter dated May 10, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter with software instruction to customers informing them about an upcoming software VB10B under(SY003/16/P) update change and issue that the new software version will address. For further questions, please call (610) 448-6478.
Quantity in commerce: 74 systems
Distribution: US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI
Product codes and lots: Serial Numbers: 100389, 100198, 100258, 100259, 100538, 100133, 100213, 100214, 100031, 100484, 100362, 100233, 100140, 100141, 100142, 100143, 100144, 100416, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100457, 100245, 100447, 100364, 100314, 100298, 100299, 100386, 100139, 100027, 100300, 100197, 100025, 100084 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100033, 100306, 100307, 100232, 100256, 100199, 100188, 100194, 100257, 100425, 100029, 100253, 100132, 100247, 100248, 100434, 100491, 100495, 100221, 100212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2088-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2088-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29

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)