Class 2 Device Recall Optical Guidance Platform, Version 2.6 and 2.6.1

• Date Initiated by Firm: March 30, 2011
• Date Posted: May 16, 2011
• Recall Status: Terminated on June 19, 2012
• Recall Number: Z-2200-2011
• Recall Event ID: 58505
• 510(K)Number: K071360
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Varian Medical Systems, Inc. Oncology Systems; 911 Hansen Way; Palo Alto CA 94304-1028
• For Additional Information Contact: Michael A. Pignataro ; 650-424-5731
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• 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.
• Quantity in Commerce: 598 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, INC.