FDA Device recall Z-2794-2016

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive…

FDA Device
Class II
terminated
Published 2016-09-21

On 2016-09-21 the FDA classified a Class II recall of Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive… by Siemens Medical Solutions Usa, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2794-2016
Classification	Class II
Status	terminated
Initiated	2016-08-02
Published	2016-09-21
Last updated	2026-09-13 11:54 UTC
Company	Siemens Medical Solutions Usa
Distribution	US

Product

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

Reason

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.

Identifiers

code_info	Model Numbers: 10863171, 10863172, 10863173, 10592457 Serial Numbers: 100262,100389,100198,100258,100259,100538,100… 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

code_info

Model Numbers: 10863171, 10863172, 10863173, 10592457 Serial Numbers: 100262,100389,100198,100258,100259,100538,100…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2794-2016%22

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