AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiog
FDA device recall Z-1711-2014 · posted 2014-06-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 field modification will be available by end of May 2014. We appreciate your understanding and cooperation with this safety advisory notice and ask you to immediately instruct your personnel accordingly. Please ensure that this safety advisory notice is placed in the system's instructions for use until the update has been installed. If you have sold this device/equipment and it is no longer in your possession, we kindly ask that you forward this safety notice to the new owner of this device/equipment. Please inform us about the new owner of the device/equipment. For further questions please call (610) 219-6300.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 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.
- Date initiated
- 2014-04-11
- Date posted
- 2014-06-04
- Date terminated
- 2014-12-15
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM LUMINOS DRF (K062623) | Siemens Medical Solutions USA, Inc. | 2007-08-22 |