Reported Nov 26, 2014 · Terminated
Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 51 Valley Stream Pkwy · Malvern, PA · 19355
Is this the product you have?
- Siemens SimView NT and SimView NT
- with IDI simulation system componentsProduct
- UsageThe intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer
- Lot codes and dates
- Model numbers
54969925497016
- with Serial numbers
603560806029603260196001
- Model numbers
- Amount recalled
- 6
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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