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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 Device Recall SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = KPQ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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