Events

Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems, Inc. Oncology Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61012
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0945-2012
  • 사례 시작날짜
    2011-11-10
  • 사례 출판 날짜
    2012-02-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107038
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with the treatment field defined by the brainlab m3 without an interlock being asserted.
  • 조치
    The firm, Varian Medical Systems, Inc., sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated November 10, 2011 to all affected users. The letter describes the product, description of problem, details, recommended actions and Varian's actions. Varian Service will contact customers to arrange installation, once modifications are available. ***12-12-12, 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 also included special instructions for customers outside the USA and Canada. The customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems once they have read the document. If you require further clarification, feel fee to contact your local Varian Customer Support District or Regional Manager at: USA and Canada: 1-888-VARIANS (1-888-827-4265); Europe: +41 41 749 8844; or Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com; Latin America: soporte.al@varian.com or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.

Device

Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL
  • 모델명 / 제조번호(시리얼번호)
    H530001 ,H530075 ,H530439 ,H533043 ,H535023 ,H535082 ,H535128 ,H535180 ,H535220 ,H530004 ,H530078 ,H531008 ,H534004 ,H535024 ,H535084 ,H535131 ,H535181 ,H535867 ,H530008 ,H530082 ,H531010 ,H534015 ,H535025 ,H535085 ,H535133 ,H535182 ,H536005 ,H530012 ,H530084 ,H531020 ,H534020 ,H535030 ,H535086 ,H535135 ,H535183 ,H536452 ,H530014 ,H530085 ,H531025 ,H534021 ,H535031 ,H535087 ,H535137 ,H535184 ,H536465 ,H530018 ,H530087 ,H531029 ,H534022 ,H535033 ,H535088 ,H535141 ,H535186 ,H536479 ,H530021 ,H530104 ,H531033 ,H534026 ,H535035 ,H535091 ,H535142 ,H535188 ,H530022 ,H530204 ,H531035 ,H534032 ,H535036 ,H535094 ,H535144 ,H535190 ,H530023 ,H530231 ,H531038 ,H534036 ,H535039 ,H535098 ,H535147 ,H535191 ,H530024 ,H530250 ,H531041 ,H534040 ,H535043 ,H535099 ,H535149 ,H535192 ,H530030 ,H530311 ,H531043 ,H534223 ,H535044 ,H535100 ,H535151 ,H535193 ,H530034 ,H530323 ,H531044 ,H535003 ,H535045 ,H535104 ,H535154 ,H535194 ,H530035 ,H530339 ,H532005 ,H535004 ,H535046 ,H535105 ,H535157 ,H535195 ,H530036 ,H530340 ,H532006 ,H535005 ,H535047 ,H535106 ,H535159 ,H535197 ,H530045 ,H530396 ,H532014 ,H535008 ,H535053 ,H535108 ,H535161 ,H535199 ,H530046 ,H530401 ,H532021 ,H535009 ,H535054 ,H535109 ,H535162 ,H535200 ,H530049 ,H530405 ,H532027 ,H535012 ,H535055 ,H535111 ,H535164 ,H535201 ,H530050 ,H530417 ,H533004 ,H535013 ,H535056 ,H535115 ,H535166 ,H535207 ,H530051 ,H530423 ,H533008 ,H535014 ,H535058 ,H535116 ,H535167 ,H535209 ,H530055 ,H530425 ,H533014 ,H535015 ,H535068 ,H535117 ,H535168 ,H535211 ,H530057 ,H530427 ,H533027 ,H535016 ,H535070 ,H535120 ,H535169 ,H535213 ,H530063 ,H530428 ,H533028 ,H535017 ,H535072 ,H535121 ,H535173 ,H535214 ,H530064 ,H530429 ,H533029 ,H535018 ,H535073 ,H535122 ,H535176 ,H535215 ,H530066 ,H530430 ,H533036 ,H535020 ,H535076 ,H535123 ,H535177 ,H535218 ,H530068 ,H530433 ,H533037 ,H535021 ,H535081 ,H535124 ,H535178 ,H535219,  ***12-12-12, AMENDED INFO ***: ,H513353 ,H51B100 ,H514449 ,H51B240 ,H517726 ,H51B242 ,H51B083 ,H51B320
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Algeria, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Korea, Spain, Sri Lanka, Sweden, Taiwan, Turkey, United Kingdom and Venezuela.
  • 제품 설명
    Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • 제조사 주소
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • 제조사 모회사 (2017)
    Varian Medical Systems Inc
  • Source
    USFDA