Device Alert
Problem: In a February 10, 2011, Urgent Safety Notice letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM), Ziehm states that the double footswitch used with the above c-arm systems may fail to switch off radiation, potentially resulting in unintentional radiation exposure. The manufacturer has not confirmed the information provided in the source material. Regulatory Agency: Designation: BfArM Reference No. 0533/11 Action Needed: Verify that you have received the February 10, 2011, Urgent Safety Notice letter, replacement footswitch, instructions, and confirmation form from Ziehm. Identify any affected product in your inventory. Replace the footswitch and discard the old footswitch in accordance with your facility’s regulations or return the old footswitch to Ziehm by mail at the above address. Complete the confirmation form, and return it to Ziehm by fax at 49 (911) 2172589. For Further Information: Geographic Location: Contact: Website:
Tue Mar 01 2011