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U.S. Department of Health and Human Services

Class 2 Device Recall Varian OnBoard Imager

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  Class 2 Device Recall Varian OnBoard Imager see related information
Date Initiated by Firm April 30, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on March 16, 2015
Recall Number Z-0526-2015
Recall Event ID 69637
510(K)Number K042720  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Varian On-Board Imager Advanced Imaging System.

The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
Code Information Part Number P1003290001
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffery Semone
650-424-6833
Manufacturer Reason
for Recall		 Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc­ tion assembly cable and the ground stud on the lid of the High Voltage Module.
FDA Determined
Cause 2		 Component change control
Action Varian will work with affected customers to establish schedules that minimize impact to their clinic's treatment schedule and send Field Service Engineers with the required hardware to each affected site to make the modification.
Quantity in Commerce 32 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 = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS
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