FDAClass IIAugust 21, 2013

Siemens syngo.plaza SW version VA20 with Mammography recall

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

Why was Siemens syngo.plaza SW version VA20 with Mammography recalled?

Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

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, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.

Product
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
6
Distribution
Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
Recall date
August 21, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls