PHILIPS VERADIUS C-ARM

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: (B)(6) (CS) CALLED TO REPORT THAT THE SYSTEM IS SHOWING "RECEIVING DICOM" ON THE C-ARM SET UP PAGE, BUT NO IMAGES ARE PUSHING OVER. CS CONFIRMED NO IMAGES WERE SENDING WITH OR WITHOUT THE TRACKER ON THE C-ARM. CS USING A PHILIPS VERADIUS MODEL. NO IMAGES ON C-ARM SET UP AND NO IMAGES IN IMAGES OR PATIENT TAB. NO PATIENT. AS PER (B)(6) (CS) EMAIL UPDATE, ISSUE WAS RESOLVED AFTER SELECTING "XA" INSTEAD OF "RF" ON THE PHILLIPS SERVICE CONSOLE. AFTER THEY SELECTED IT, REBOOTED IMAGES TRANSFERRED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).