FDAClass IISeptember 5, 2012

syngo.plaza recall

syngo.plaza, Model number 10592457. Intended use: radiological image processing system.

Why was syngo.plaza recalled?

There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.

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?

Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.

Product
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
14
Distribution
Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Recall date
September 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls