FDAClass IIJuly 8, 2015

Syngo Imaging recall

SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report…

Why was Syngo Imaging recalled?

During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.

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: 10014064 serial numbers: 5846 5847 4333 4334 4335

Product
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
5
Distribution
US in the states of NC and NE
Recall date
July 8, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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