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Terminated

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

FDA Recall Z-0646-2009 · Posted 2009-01-13

Recall StatusTerminated
Product CodeKPQ
Date Initiated2008-11-06
Date Terminated2010-12-09
Product Quantity223 units

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.

Firm 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).

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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