Recall Z-0646-2009 ยท KPQ System, Simulation, Radiation Therapy
Siemens Medical Solutions USA, Inc
Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system.
| Date | Jan 13, 2009 (initiated Nov 6, 2008) |
| Status | Terminated |
| Reason | Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury. |
| Root cause | Device Design |
| Action | Firm has reissued the Urgent Medical Device Customer Letter regarding the belt replacement and a reminder message to replace the belts yearly during the annual Preventative Maintenance. The letter requests that customers follow the guidelines, which consist of making any required SAD adjustments utilizing the Image Intensifier drive, the X-Ray Head Drive, or both; being vigilant of any change in the type or level of noise from either of the drive belt assemblies while they are in use as this may be an indication of wear; discontinuing clinical operation if there is any doubt, and contacting t |
| Quantity | 223 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |