Device Recall SIMVIEW NT and SIMVIEW NT with IDI: 의 리콜

Recall

67153

Class 2

Z-0786-2014

2013-12-11

2014-01-17

Terminated

United States

2014-03-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124791

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.

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 trained about the use of the emergency button / stop button inside the simulation room and on the control console. Always monitor any movement of the simulator components. The Update Instruction containing the Urgent Field Safety Notice will be delivered by the Siemens Customer Service Group, as per their procedure Siemens is working on a solution to mitigate the described situation. You will be informed as soon as the update distributing this solution is available. Please include this Field Safety Notice in your SimView NT Simulator System Owner Manual chapter Safety Advisory Letters where it should remain. In the interests of safety, we ask that you perform the described preventive measures and inform all affected personnel immediately. The relevant National Competent Authority has been informed of this Customer Safety Advisory Notice. We regret any inconvenience that this may cause, and we thank you in advance for your understanding. For further questions please call (925) 602-8157.