Date Initiated by Firm | November 06, 2008 |
Date Posted | January 13, 2009 |
Recall Status1 |
Terminated 3 on December 09, 2010 |
Recall Number | Z-0646-2009 |
Recall Event ID |
50480 |
510(K)Number | K946053 K953233 |
Product Classification |
Radiation Therapy Simulation System - Product Code KPQ
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Product | Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.
Radiation therapy simulation system. |
Code Information |
all drive belts in SIMVIEW 3000 and NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984. |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 4040 Nelson Ave Concord CA 94520-1200
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For Additional Information Contact | 925-246-8407 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KPQ
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