FDAClass IIDecember 2, 2015

Syngo Imaging VB36D_HF02. Radiological image processing recall: Software Issue

Syngo Imaging VB36D_HF02. Radiological image processing system.

Why was Syngo Imaging VB36D_HF02. Radiological image processing recalled?

To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.

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# 10014063 and 10014064

Product
Syngo Imaging VB36D_HF02. Radiological image processing system.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
3
Distribution
US Distribution to the states of : NC, NE and OH.
Recall date
December 2, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls