Recall Z-1583-2015 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with t
| Date | May 5, 2015 (initiated Apr 14, 2015) |
| Status | Terminated |
| Reason | If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators. |
| Root cause | Device Design |
| Action | The firm, Siemens Healthcare, sent a "Safety Advisory Notice" dated April 14, 2015, to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions in the notice; promptly notify and instruct all the staff at your organization making them aware of the problem; and forward this safety information to other organizations that could be affected. If the device has been sold and therefore no longer in your possession, forward the safety notice to the new owner. Additionally, customers were instructed observe this safety n |
| Quantity | 43 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013826 | AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) Siemens Medical Systems, Inc., Feb 1, 2002 |