| Reason for the Action |
Philips has identified that, when the Wireless Foot Switch is used for vascular procedures (i.e., with the vascular protocol) in conjunction with the Zenition 70 system, there may be a delay of up to 72 milliseconds in the command to stop the radiation when the user releases the pedal of the Wireless Foot Switch. This problem can only occur during a vascular procedure using 2fps (frames per second) subtract mode. During a typical vascular procedure, the vascular protocol may be used up to 15 times, resulting in a maximum estimated additional radiation dose to the patient of 0.0012 mSv.
Based on this minimal additional dose, it is considered unlikely to contribute to any immediate or long-term health effects from radiation exposure. To date, Philips has not received any complaints associated with this problem. |