Events

Recall of Device Recall Optical Guidance Platform, Version 2.6 and 2.6.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58505
  • Event Risk Class
    Class 2
  • Event Number
    Z-2200-2011
  • Event Initiated Date
    2011-03-30
  • Event Date Posted
    2011-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99481
  • Notes / Alerts
    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.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    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.
  • Action
    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
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA