—#75465

Product

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

FDA product code: KPQ — System, Simulation, Radiation Therapy
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K946053, K953233
Affected lot / code info: all drive belts in SIMVIEW 3000 and NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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).

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2008-11-06
Posted by FDA: 2009-01-13
Terminated: 2010-12-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75465. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.