Recall Z-0235-2015— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-10-10, terminated 2017-06-29. It names one FDA 510(k) clearance: K953233. Product: 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.. 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..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-10
- Terminated
- 2017-06-29
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.