FDAClass IISeptember 21, 2016

Syngo Plaza picture archiving and communication system recall

Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and…

Why was Syngo Plaza picture archiving and communication system recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
101 Systems
Distribution
Nationwide Distribution
Recall date
September 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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