FDAClass IIJuly 23, 2014

Siemens syngo RT Dosimetrist 2.7 system Product Usage recall: Software Issue

Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear…

Why was Siemens syngo RT Dosimetrist 2.7 system Product Usage recalled?

An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI

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?

material number: 10568604 , with serial numbers 10201 10231 10237 10266 10267 10305 10272

Product
Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
7
Distribution
US Nationwide Distribution in the states of NH, TN, OH, VA, and TX.
Recall date
July 23, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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