Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy
FDA device recall Z-0646-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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 their local Siemens Service organization to inspect the belts. Currently, the firm is distributing the current belt kit to replace the entire installed base of active SIMVIEW Simulators (3000 and NT models).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 223 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2008-11-06
- Date posted
- 2009-01-13
- Date terminated
- 2010-12-09
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMVIEW 3000 CT OPTION (K953233) | Siemens Medical Solutions USA, Inc. | 1996-11-29 |
| SIMVIEW(TM) 3000 (K946053) | Siemens Medical Solutions USA, Inc. | 1995-03-31 |