Recall Z-1097-2013 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system.
| Date | Apr 11, 2013 (initiated Jan 15, 2013) |
| Status | Terminated |
| Reason | Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This malfunction is possible in cases where the table vertical lift movement is obstructed by a solid object which could potentially result in collision. This can re |
| Root cause | Process design |
| Action | Siemens sent a Customer Safety Advisory letter dated January 15th, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The SIEMENS service representative will investigate if parts need to be exchanged in your product, an if so, which parts need to be exchanged to restore the system safety and function. Please kindly confirm receipt of the Field Safety Notice by sending back the attached form. For further questions please call (610) 448-3237. |
| Quantity | 51 |
| Distribution | Nationwide Distribution including the states of CA, FL, GA, IA, IN, KS, LA, ME, MI, MO, NC, NH, NJ, NY, NV, OH, PA, TN, TX, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992660 | URF DIGITAL - OT Siemens Medical Solutions USA, Inc., Nov 5, 1999 |