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U.S. Department of Health and Human Services

Class 2 Device Recall Head Ring Posts; of the Optical Guidance Platform and Floorstand devices

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  Class 2 Device Recall Head Ring Posts; of the Optical Guidance Platform and Floorstand devices see related information
Date Initiated by Firm October 04, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on July 25, 2012
Recall Number Z-0332-2012
Recall Event ID 60238
510(K)Number K071360  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices.
Varian Medical Systems, Palo Alto, CA 94304.

The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesions.
Code Information Model H48: Head ring Post part number 970.280 Code numbers:  HZ50004 HZ70169 HZ70426 HZ70617 HZ70743 HZ72001 HZ72037 HZ72064 HZ72089 HZ73039 HZ77007 HZ50468 HZ70181 HZ70460 HZ70620 HZ70762 HZ72002 HZ72038 HZ72067 HZ72090 HZ73041 HZ77010 HZ50567 HZ70182 HZ70465 HZ70629 HZ71001 HZ72003 HZ72039 HZ72068 HZ72091 HZ73042 HZ77011 HZ50671 HZ70190 HZ70466 HZ70640 HZ71002 HZ72004 HZ72040 HZ72069 HZ72094 HZ73044 HZ77027 HZ59006 HZ70223 HZ70486 HZ70646 HZ71003 HZ72005 HZ72041 HZ72070 HZ72095 HZ73046 HZ77040 HZ59011 HZ70231 HZ70495 HZ70649 HZ71004 HZ72006 HZ72042 HZ72071 HZ72096 HZ73047 HZ77062 HZ59014 HZ70258 HZ70500 HZ70656 HZ71005 HZ72007 HZ72043 HZ72072 HZ72098 HZ73049 HZ77069 HZ59016 HZ70273 HZ70507 HZ70670 HZ71006 HZ72008 HZ72046 HZ72073 HZ72101 HZ73050 HZ77077 HZ59017 HZ70274 HZ70508 HZ70674 HZ71007 HZ72009 HZ72047 HZ72074 HZ72103 HZ73053 HZ77081 HZ59018 HZ70283 HZ70509 HZ70675 HZ71008 HZ72012 HZ72048 HZ72075 HZ72107 HZ73055 HZ78330 HZ59020 HZ70293 HZ70513 HZ70681 HZ71009 HZ72013 HZ72049 HZ72077 HZ72108 HZ73059 HZ79012 HZ59139 HZ70294 HZ70537 HZ70684 HZ71011 HZ72015 HZ72052 HZ72080 HZ72125 HZ73060 HZ79020 HZ59997 HZ70299 HZ70540 HZ70696 HZ71013 HZ72016 HZ72054 HZ72081 HZ72126 HZ73062 HZ79113 HZ59998 HZ70351 HZ70548 HZ70698 HZ71014 HZ72023 HZ72055 HZ72082 HZ72190 HZ73064 HZ79144 HZ70044 HZ70355 HZ70550 HZ70703 HZ71017 HZ72026 HZ72056 HZ72083 HZ73020 HZ75070 HZ79185 HZ70050 HZ70368 HZ70557 HZ70712 HZ71019 HZ72027 HZ72057 HZ72084 HZ73021 HZ75480 HZ79998 HZ70061 HZ70398 HZ70585 HZ70725 HZ71021 HZ72029 HZ72058 HZ72085 HZ73022 HZ76066  HZ70083 HZ70403 HZ70594 HZ70731 HZ71022 HZ72030 HZ72060 HZ72086 HZ73026 HZ76118  HZ70108 HZ70404 HZ70603 HZ70737 HZ71023 HZ72033 HZ72061 HZ72087 HZ73030 HZ77002  HZ70154 HZ70405 HZ70612 HZ70740 HZ71024 HZ72036 HZ72062 HZ72088 HZ73031 HZ77003.  
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Michael Pignataro
650-424-6471
Manufacturer Reason
for Recall		 An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated October 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are advised to verify that they are using the current design of the head ring posts (part # 970.284) and to contact Varian if replacements are needed. Customers may contact the Varian Help Desk for questions regarding this notice at 1-888-827-4265.
Quantity in Commerce 205 kits ( Each kit contains 4 Head Post Rings) 820 HPR's
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, INC.
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