Events

Device Recall Optical Guidance Platform, Version 2.6 and 2.6.1 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
    58505
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2200-2011
  • 사례 시작날짜
    2011-03-30
  • 사례 출판 날짜
    2011-05-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99481
  • 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
    A software anomaly has been identified with the optical guidance platform (ogp) software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the fastplan system result in a lateral offset error.
  • 조치
    On 3/30/2011, Varian distributed an Urgent Medical Device Correction Urgent Field Safety Notice to all affected users, with a description of the problem and identification of the affected product. The letter also informed customers of how they can determine if the problem affects them. The letter states that there is no work around for the issue unless they possess a FastPlan system. Varian is preparing a software patch to correct the issue and it will be applied to all OGP v2.6 and v2.6.1 systems. Customers are to advise the appropriate personnel of the content of the letter. If further clarification is needed, customers are to contact their local Varian Customer Support District or Regional Manager.

Device

Device Recall Optical Guidance Platform, Version 2.6 and 2.6.1
  • 모델명 / 제조번호(시리얼번호)
    HZlOOO3 ,HZlO153 ,HZI0313 ,HZI0513 ,HZI0679 ,HZl1020 ,HZ12046 ,HZ12097 ,HZ13059 ,HZ17058 ,HZ18118  ,HZlOOO8 ,HZI0154 ,HZ10316 ,HZI0528 ,HZlO681 ,HZl1021 ,HZ12047 ,HZ12098 ,HZ13060 ,HZ17059 ,HZ18120  ,HZIOO13 ,HZI0155 ,HZ10326 ,HZI0534 ,HZI0684 ,HZl1022 ,HZ12048 ,HZ12099 ,HZ13062 ,HZ17061 ,HZ18126  ,HZIOO14 ,HZI0157 ,HZ10330 ,HZI0537 ,HZ10685 ,HZl1023 ,HZ12049 ,HZl2100 ,HZ13063 ,HZ17062 ,HZ18131  ,HZlOO15 ,HZI0159 ,HZI0333 ,HZ10540 ,HZ10689 ,HZl1024 ,HZ12050 ,HZl2101 ,HZ13064 ,HZ17065 ,HZ18132  ,HZIOO17 ,HZI0165 ,HZI0335 ,HZI0541 ,HZ10693 ,HZl1025 ,HZ12051 ,HZl2102 ,HZ15006 ,HZ17067 ,HZ18134   ,HZIOO19 ,HZI0170 ,HZI0337 ,HZ10542 ,HZI0698 ,HZ12001 ,HZ12052 ,HZ12103 ,HZ15070 ,HZ17068 ,HZ18142  ,HZIOO23 ,HZlOl72 ,HZI0343 ,HZI0544 ,HZ10700 ,HZ12002 ,HZ12054 ,HZ12104 ,HZ15118 ,HZ17069 ,HZ18143  ,HZlOO24 ,HZI0179 ,HZ10347 ,HZ10545 ,HZI0703 ,HZ12003 ,HZ12056 ,HZ12107 ,HZ15480 ,HZ17070 ,HZ18155  ,HZlOO25 ,HZI0181 ,HZI0352 ,HZ10547 ,HZ10706 ,HZ12004 ,HZ12057 ,HZ12108 ,HZ16006 ,HZ17071 ,HZ18175  ,HZIOO26 ,HZI0182 ,HZI0357 ,HZ10552 ,HZI0712 ,HZ12005 ,HZ12058 ,HZ12125 ,HZ16069 ,HZ17072 ,HZ18188  ,HZIOO27 ,HZI0183 ,HZI0368 ,HZ10553 ,HZlO715 ,HZ12006 ,HZ12059 ,HZ12126 ,HZ16070 ,HZ17074 ,HZ18193  ,HZIOO29 ,HZI0185 ,HZI0372 ,HZI0557 ,HZI0717 ,HZ12007 ,HZl2060 ,HZ12154 ,HZ17001 ,HZ17078 ,HZ19001  ,HZIOO44 ,HZI0187 ,HZ10376 ,HZI0560 ,HZI0722 ,HZ12008 ,HZ12061 ,HZ12188 ,HZ17002 ,HZ17079 ,HZ19003  ,HZIOO46 ,HZI0188 ,HZ10378 ,HZI0562 ,HZI0724 ,HZ12009 ,HZ12062 ,HZ12190 ,HZ17003 ,HZ17081 ,HZ19004  ,HZlOO48 ,HZI0190 ,HZ10379 ,HZ10568 ,HZlO728 ,HZ12010 ,HZ12063 ,HZ13006 ,HZ17006 ,HZ17106 ,HZ19cio5  ,HZIOO51 ,HZI0194 ,HZI0387 ,HZ10580 ,HZ10730 ,HZ12011 ,HZ12064 ,HZ13009 ,HZ17007 ,HZ17118 ,HZ19006  ,HZlOO52 ,HZI0196 ,HZI0392 ,HZI0584 ,HZ10731 ,HZ12012 ,HZ12065 ,HZ13013 ,HZ17010 ,HZl7126 ,HZ19007  ,HZlOO54 ,HZ10201 ,HZI0394 ,HZI0591 ,HZ10733 ,HZ12013 ,HZ12066 ,HZ13019 ,HZ17011 ,HZ17137 ,HZ19010  ,HZIOO55 ,HZ10203 ,HZ10398 ,HZI0592 ,HZI0737 ,HZ12015 ,HZ12067 ,HZ13020 ,HZ17012 ,HZl7142 ,HZ19012  ,HZIOO58 ,HZ10205 ,HZI0401 ,HZI0594 ,HZI0740 ,HZ12016 ,HZ12068 ,HZ13021 ,HZ17013 ,HZl7175 ,HZ19013  ,HZIOO61 ,HZI0209 ,HZI0403 ,HZI0598 ,HZI0743 ,HZ12018 ,HZ12069 ,HZ13022 ,HZ17016 ,HZ18001 ,HZ19014  ,HZlOO63 ,HZ10210 ,HZ10404 ,HZ10601 ,HZ10744 ,HZ12019 ,HZ12070 ,HZ13023 ,HZ17017 ,HZ18002 ,HZ19015  ,HZlOO65 ,HZ10220 ,HZ10408 ,HZI0607 ,HZI0759 ,HZ12020 ,HZ12071 ,HZ13024 ,HZ17018 ,HZ18004 ,HZ19017  ,HZIOO68 ,HZI0228 ,HZI0409 ,HZI0609 ,HZI0762 ,HZ12021 ,HZ12072 ,HZ13026 ,HZ17019 ,HZ18006 ,HZ19018  ,HZIOO70 ,HZI0237 ,HZI0411 ,HZI0611 ,HZI0764 ,HZ12022 ,HZ12073 ,HZ13029 ,HZ17020 ,HZ18013 ,HZ19019  ,HZIOO73 ,HZI0239 ,HZ10412 ,HZ10612 ,HZ10766 ,HZ12023 ,HZ12074 ,HZ13030 ,HZ17021 ,HZ18018 ,HZ19020  ,HZlOO76 ,HZI0240 ,HZI0425 ,HZI0613 ,HZI0771 ,HZ12024 ,HZ12075 ,HZ13031 ,HZ17023 ,HZ18020 ,HZ19023  ,HZlOO83 ,HZ10242 ,HZ10426 ,HZ10617 ,HZI0774 ,HZ12026 ,HZ12076 ,HZ13032 ,HZ17024 ,HZ18022 ,HZ19025  ,HZIOO84 ,HZ10245 ,HZI0430 ,HZI0620 ,HZI0776 ,HZ12027 ,HZ12077 ,HZ13038 ,HZ17027 ,HZ18024 ,HZ19026  ,HZlOO86 ,HZ10247 ,HZI0434 ,HZI0627 ,HZI0778 ,HZ12028 ,HZ12078 ,HZ13039 ,HZ17028 ,HZ18026 ,HZ19028  ,HZIOO88 ,HZI0249 ,HZI0438 ,HZI0629 ,HZll001 ,HZ12029 ,HZ12080 ,HZ13041 ,HZ17030 ,HZ18035 ,HZ19029  ,HZlOO90 ,HZI0254 ,HZI0442 ,HZI0632 ,HZll002 ,HZ12030 ,HZ12081 ,HZ13042 ,HZ17032 ,HZ18040 ,HZ19033  ,HZIOO92 ,HZI0257 ,HZI0450 ,HZI0640 ,HZll003 ,HZ12031 ,HZ12082 ,HZ13043 ,HZ17034 ,HZ18041 ,HZ19034  ,HZlOO95 ,HZI0258 ,HZI0453 ,HZI0644 ,HZll004 ,HZ12032 ,HZ12083 ,HZ13044 ,HZ17035 ,HZ18042 ,HZ19035  ,HZIOO98 ,HZI0260 ,HZI0460 ,HZI0646 ,HZll005 ,HZ12033 ,HZ12084 ,HZ13045 ,HZ17036 ,HZ18043 ,HZ19036  ,HZIOI02 ,HZ10271 ,HZI0467 ,HZI0647 ,HZll006 ,HZ12034 ,HZ12085 ,HZ13046 ,HZ17037 ,HZ18046 ,HZ19040  ,HZIOI08 ,HZI0273 ,HZI0479 ,HZI0649 ,HZll007 ,HZ12035 ,HZ12086 ,HZ13047 ,HZ17039 ,HZ18048 ,HZ19041  ,HZIOll0 ,HZ10274 ,HZI0489 ,HZI0650 ,HZll008 ,HZ12036 ,HZ12087 ,HZ13048 ,HZ17040 ,HZ18062 ,HZ19043  ,HZI0116 ,HZI0283 ,HZ10493 ,HZ10652 ,HZll010 ,HZ12037 ,HZ12088 ,HZ13049 ,HZ17041 ,HZ18066 ,HZ19044  ,HZI0117 ,HZI0293 ,HZI0495 ,HZ10656 ,HZll0ll ,HZ12038 ,HZ12089 ,HZ13050 ,HZ17042 ,HZ18068 ,HZ19045  ,HZI0121 ,HZlO294 ,HZI0496 ,HZI0659 ,HZll013 ,HZ12039 ,HZ12090 ,HZ13052 ,HZ17043 ,HZ18069 ,HZ19046  ,HZI0126 ,HZI0295 ,HZ10497 ,HZI0663 ,HZll014 ,HZ12040 ,HZ12091 ,HZ13053 ,HZ17044 ,HZ18070 ,HZ19051  ,HZI0138 ,HZI0297 ,HZI0500 ,HZ10665 ,HZll015 ,HZ12041 ,HZ12092 ,HZ13054 ,HZ17046 ,HZ18076 ,HZ19052  ,HZI0144 ,HZ10299 ,HZ10501 ,HZ10670 ,HZll016 ,HZ12042 ,HZ12093 ,HZ13055 ,HZ17048 ,HZ18077 ,HZ19053  ,HZlO146 ,HZlO303 ,HZI0507 ,HZI0674 ,HZll017 ,HZ12043 ,HZ12094 ,HZ13056 ,HZ17049 ,HZ18079 ,HZ19055  ,HZlO148 ,HZI0305 ,HZI0508 ,HZI0675 ,HZll018 ,HZ12044 ,HZ12095 ,HZ13057 ,HZ17051 ,HZ18085 ,HZ19056  ,HZlO151 ,HZI0311 ,HZI0509 ,HZI0676 ,HZll019 ,HZ12045 ,HZ12096 ,HZ13058 ,HZ17057 ,HZ18088 ,HZ19059   ,HZ19060 ,HZ19086 ,HZl9109 ,HZ19129 ,HZ19158 ,HZ19193 ,HZ19926   ,HZ19062 ,HZ19087 ,HZ19113 ,HZ19130 ,HZ19159 ,HZ19194 ,HZ19996   ,HZ19065 ,HZ19088 ,HZ19114 ,HZ19131 ,HZ19162 ,HZ19195 ,HZ19997   ,HZ19066 ,HZ19089 ,HZ19115 ,HZ19133 ,HZ19167 ,HZ19201 ,HZ19998   ,HZl9068 ,HZ19091 ,HZl9117 ,HZ19134 ,HZ19170 ,HZ19226   ,HZ19069 ,HZ19095 ,HZ19118 ,HZ19135 ,HZ19171 ,HZ19227   ,HZ19071 ,HZ19096 ,HZ19119 ,HZ19140 ,HZ19172 ,HZ19228   ,HZ19072 ,HZ19098 ,HZ19121 ,HZ19141 ,HZ19179 ,HZ19229   ,HZ19076 ,HZ19099 ,HZ19125 ,HZ19142 ,HZ19186 ,HZ19235   ,HZ19078 ,HZ19104 ,HZ19126 ,HZ19143 ,HZl9189 ,HZ19236   ,HZ19079 ,HZ19106 ,HZ19128 ,HZ19155 ,HZ19190 , and HZ19611.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. || For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
  • 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