Recall Z-0786-2014 ยท KPQ System, Simulation, Radiation Therapy
Siemens Medical Solutions USA, Inc
SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.
| Date | Jan 17, 2014 (initiated Dec 11, 2013) |
| Status | Terminated |
| Reason | In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality. |
| Root cause | Device Design |
| Action | Siemens sent an Urgent Field Safety Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. What preventive measures can the user take? To stop the movement in this case, push the emergency button / stop button at control console or push the in-room emergency button. The emergency button/ stop button functionality is described in the User Manual. There is no preventive measure to avoid this situation. This letter is intended to bring this potential safety issue to your awareness and to ensure that your personnel are t |
| Quantity | 65 active devices |
| Distribution | Class II Recall - Worldwide Distribution - US Distribution including the states of California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky and Michigan., and the countries of Bulgaria, Germany, Belarus, Russian Fed., P.R. China, India, Republic Korea, Germany, Costa Rica, Argentina, |
| 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 |