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U.S. Department of Health and Human Services

Class 2 Device Recall HighDefinition 120 Multileaf Collimator (HD120 MLC)

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  Class 2 Device Recall HighDefinition 120 Multileaf Collimator (HD120 MLC) see related information
Date Initiated by Firm June 06, 2011
Date Posted August 22, 2011
Recall Status1 Terminated 3 on December 23, 2011
Recall Number Z-3052-2011
Recall Event ID 59226
510(K)Number K071992  
Product Classification Accelerator, linear, medical - Product Code IYE
Product High-Definition 120 Multileaf Collimator

HD 120 MLC is an accessory x-ray collimator designed to be mounted on Varian Trilogy Tx and Trilogy linear accelerators and is intended to shape s-ray field perimeter. Field shape can be either static (fixed) or dynamic. The intended use is to assist clinician in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Code Information Model Numbers: H56, HHM; Code numbers: HHM0018, HHM1202, H561174, H561044, H561076, H561016, H561142, H561040, H561176, H561170, H561111 H561011, H561154, H561017, H561141, H561172, H561163, H561205, H561178, H561121, HHM0028, H561156, HHM0017, H561130, H561137 H561008, H561010, H561191, H561162, H561187, H561147, H561009, H561203 HHM0035 HHM0039, H561206 H561159 H561152 HHM0005 HHM0023 H561027 H561144 H561166 H561146 H561067 H561190 H561140 H561034 H561050 H561112 H561046 HHM0012 HHM0010 H561123 H561113 H561173 H561106 H561114 H561020 HHM0033 H561118 H561195 H561064 H561096 HHM0019 H561193 H561138 H561148 H561061 H561059 H561185 H561169 H561041 H561151 HHM0007 H561204 HHM0006 H561117 H561052 H561136 H561179 HHM0032 H561150 H561045 H561157 H561175 H561116 H561037 HHM0030 H561018 H561199 H561167 H561063 H561028 H561194 H561023 H561070 H561153 H561145 H561043 H561171 H561180 H561127 H561201 H561107 H561048 H561104 H561026 H561139 H561160 H561207 H561208 HHM0029 HHM0016 HHM0024 H561031 H561025 H561062 H561006 H561057 H561200 H561182 HHM0014 H561186 HHM0025 H561021 H561158 H561105 H561126 HHM0027 H561161 H561033 H563989 HHM0009 H561134 H561101 H561069 H564795 H561102 H561030 H561168 H561128 H561109 H561120 H561196 HHM0015 H561135 H561115 H561013 H561110 H561058 H561035 H561100 HHM0013 H561053 H561019 H561149 HHM0031 HHM0008 H561012 H561024 H561022 H561103 H561039 H561038 H561124 HHM0026 HHM0004 H561189 H561036 H561029 H561015 H561060  ***12-20-12, AMENDED INFO ***: HHM0022, H561233, H561221
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		 When using the HD120 Multi Leaf Collimator for beam shaping, and under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 6, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter describes various jaw position recommendations to be followed when planning and treating dynamic fields on the HD120 MLC. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.
Quantity in Commerce 173***12-20-12 AMENDED TO: 106 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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