FDAClass IIAugust 1, 2012

Siemens syngo.plaza. Radiological image processing recall: Software Issue

Siemens syngo.plaza. Radiological image processing system

Why was Siemens syngo.plaza. Radiological image processing recalled?

Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

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 number 10592457

Product
Siemens syngo.plaza. Radiological image processing system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
2
Distribution
(USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Recall date
August 1, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls