Device Recall Barcode Conical Collimator Verification (BCCV)

  • 모델명 / 제조번호(시리얼번호)
    ,HBC0001 , H512022 , H511551 , H511275 ,HBC0004 ,H512993 ,H513292 ,H515900 ,HBC0007 ,H512781 ,H513115 ,H511691 ,HBC0018 ,H512241 ,H515092 ,H513533 ,HBC0021 ,H513561 ,H514438 ,H515524 ,HBC0024 ,H510889 ,H512278 ,H513927 ,HBC0028 ,H515461 ,H515076 ,H514202 ,HBC0048 ,H510126 ,H513080 ,H515780 ,HBC0069 ,H515541 ,H512967 ,H515068 ,HBC0070 ,H511840 ,H513262 ,H510732 ,HBC0075 ,H514160 ,H513701 ,H511593 ,HBC0079 ,H513117 ,H513551 ,H514018 ,HBC0083 ,H511663 ,H511565 ,H512454 ,HBC0090 ,H513989 ,H515570 ,H515064 ,HBC0097 ,H512618 ,H512464 ,H515737 ,HBC0106 ,H514439 ,H515943 ,H515696 ,HBC0111 ,H515691 ,H511821 ,H515523 ,HBC0115 ,H515998 ,H514402 ,H514521 ,HBC0174 ,H515387 ,H514403 ,H513548 ,HBC0210 ,H513769 ,H514080 ,HBC0211 ,H515262 ,H513002 ,HBC0348 ,H514488 ,H512998
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution:USA (nationwide) and countries of: Canada, Australia, Austria, Brazil, China, France, Georgia, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Macau. Malaysia, Mexico, Netherlands, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom..
  • 제품 설명
    Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB, distributed by and/or manufactured by: || Varian Medical Systems Inc., Palo Alto, CA || The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
  • Manufacturer
  • 1 Event

제조사

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