Recall Z-0235-2015 ยท KPQ System, Simulation, Radiation Therapy
Siemens Medical Solutions USA, Inc
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.
| Date | Nov 20, 2014 (initiated Oct 10, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Customers were initially notified about the issue by letter on January 7, 2014 (this action was reported as Z-0786-2014 which has been terminated). Siemens promised to notify them when a fix became available. Customer letter, dated November 7, 2014, was sent to notify end users that a fix has become available and Siemens would contact them to schedule an appointment for the correction. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953233 | SIMVIEW 3000 CT OPTION Siemens Medical Solutions USA, Inc., Nov 29, 1996 |