Z-2793-2016Class II

Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read...

Name: Z-2793-2016 Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-08-02
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-08-02 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive... on 2016-08-02. FDA classified it as Class II and gives the reason as "Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2793-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-02
Posted: 2016-09-14
Terminated: 2017-03-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Product code: LLG Kit, Igg, Platelet Associated
Reason for recall: Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Siemens mailed to customers on August 04, 2016 a Customer Advisory Notice that provided interpretations about the meaning of measurement values like area, distance and perimeter shown as "o.p." by the syngo.plaza.
Quantity in commerce: 101 Systems
Distribution: Nationwide Distribution
Product codes and lots: Model Numbers: 10863171, 10863172, 10863173, 10592457 Serial Numbers: 100262,100389,100198,100258,100259,100538,100135,100133,100213,100214,100031,100032,100484,100362,100233,100140,100141,100142,100143,100144,100416,100105,100106,100109,100110,100111,100112,100113,100114,100115,100116,100117,100119,100120,100461,100457,100245,100447,100364,100314,100298,100299,100386,200277,100139,100027,100028,100300,100559,100440,100441,100197,100170,100025,100026,100084,100186,100189,100190,100191,100192,100195,100196,100550,100033,100034,100306,100307,100232,100449,100450,100185,100596,100256,100199,100188,100193,100194,100257,100226,100228,100425,100029,100030,100253,100203,100204,100132,100247,100248,100434,100215,100491,100495,100230,100221,100212,100539,100206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2793-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2793-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14
Z-2794-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-14

Product code LLG

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)