FDAClass IIAugust 29, 2012

syngo Dynamics Version 9.5 recall

syngo Dynamics Version 9.5

Why was syngo Dynamics Version 9.5 recalled?

If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.

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?

10091862 and 10091863

Product
syngo Dynamics Version 9.5
Recalling firm
Siemens Medical Solutions, USA, Inc
Quantity
30
Distribution
Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
Recall date
August 29, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls