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U.S. Department of Health and Human Services

Class 2 Device Recall SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.

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 Class 2 Recall
SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.
see related information
Date Posted January 13, 2009
Recall Status1 Open
Recall Number Z-0646-2009
Recall Event ID 50480
Premarket Notification
510(K) Numbers
K946053  K953233 
Product Classification System, Simulation, Radiation Therapy - Product Code KPQ
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, California 94520-1200
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
DESIGN: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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