Recall Z-2526-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
| Date | May 25, 2018 |
| Status | Terminated |
| Reason | Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure |
| Root cause | Process control |
| Action | Siemens issued on May 25, 2018 an URGENT: MEDICAL DEVICE CORRECTION customer notification to affected customers and advised a hardware update will be initiated . Users advised of the problem, potential risks and action to be taken. Siemens will correct the error by replacing all affected cooling units with Update Instruction AX076/17/S. Users may continue to use the Artis system while awaiting implementation of the corrective action. |
| Quantity | 3 US |
| Distribution | HI , IL, MI, NC, NY, VA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141574 | ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc., Sep 5, 2014 |