Recall Z-1711-2014 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray i
| Date | Jun 4, 2014 (initiated Apr 11, 2014) |
| Status | Terminated |
| Reason | It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients, operating personnel or to the unit. |
| Root cause | Device Design |
| Action | Siemens sent an Safety Advisory Notice dated April 11, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. What steps can the user take to avoid the potential risk of this issue? Press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again. How will the issue finally be resolved? Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The fie |
| Quantity | 37 |
| Distribution | Class II Recall - US Distribution including the states of IL,VA, TN, PA, TX, MN, GA, MI, IN, OH, FL, CA, OR, NY, ME, MO, OK, CO and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062623 | AXIOM LUMINOS DRF Siemens Medical Solutions USA, Inc., Aug 22, 2007 |