FDA Device

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging

Hazard

Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.

What You Should Do

Remedy

Ziehm Imaging, Inc planned action to bring these defects into compliance: 1. You will contact customers and initiate a software update to correct the defects. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (866) 949-4346.

Products

Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Brand
Ziehm Imaging Inc
UPC
Serial #'s 20628, 20657, 20658, 20659, 20660, 20671, 20672, 20678, 20679, 20680, 20681, 20682, 20683, 20684, 20685, 20686, 20687, 20712, 10713, 20714, 20715, 20717, 20718, 20722, 20723, 20724, 20725, 20726, 20772, 20793, and 20794.

Units Affected

31 devices