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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 18, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on August 12, 2010
Recall Number Z-1195-2007
Recall Event ID 38349
510(K)Number K042720  K041519  K040192  
Product Classification Medical Linear Accelerator - Product Code IYE
Product Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
Code Information serial numbers H070002-H072113
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		 Patient positioning errors may occur because of mechanical variations during product installation.
FDA Determined
Cause 2		 Device Design
Action The firm issued a notification letter to all customers April 18, 2007. The firm intends to arrange for service personnel to contact affected sites to verify the calibration of the OBI system, and make arrangements to correct any issues. The firm will also update installation manuals to clearly describe the OBI installation and calibration requirements.
Quantity in Commerce 291 units
Distribution Worldwide, including USA, Puerto Rico, Australia, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Luxembourg, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Netherlands, and United Kingdom.
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
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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