FDAClass IINovember 26, 2014

Siemens SimView NT and SimView NT with IDI simulation recall

Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is…

Why was Siemens SimView NT and SimView NT with IDI simulation recalled?

Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.

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 numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001

Product
Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
6
Distribution
Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.
Recall date
November 26, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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