FDAFDA · Food and drugs·Recall number Z-0235-2015
Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
Published November 26, 2014 · Recall initiated: October 10, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- 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.
- Lot
- Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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