FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0646-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system.
- Status
- Terminated
- Initiated
- 2008-11-06
- Posted
- 2009-01-13
- Terminated
- 2010-12-09
- 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 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).
- Quantity
- 223 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- all drive belts in SIMVIEW 3000 and NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984.
- 510(k) numbers
- ["K946053","K953233"]
- PMA numbers
- not on file
- Product code
- KPQ
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28