Z-0646-2009

Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI...

Name: Z-0646-2009 Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI...
Creator: Siemens Medical Solutions USA, Inc
Published: 2008-11-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-11-06 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system on 2008-11-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0646-2009
Status: Terminated
Initiated: 2008-11-06
Posted: 2009-01-13
Terminated: 2010-12-09
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.
Product code: KPQ System, Simulation, Radiation Therapy
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.
Root cause tag: design
FDA 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 in commerce: 223 units
Distribution: Worldwide Distribution
Product codes and lots: all drive belts in SIMVIEW 3000 and NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984.

Product code KPQ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)