Varian Medical Systems, Inc. Oncology Systems: 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.

Recall number

Z-2200-2011

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

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.

Status

Terminated

Initiated

2011-03-30

Posted

2011-05-16

Terminated

2012-06-19

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.

Root 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

598 units

Distribution

Worldwide Distribution

Lot, serial or model codes

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.

510(k) numbers

["K071360"]

PMA numbers

not on file

Product code

IYE

Firm FEI

2916710

Firm city

Palo Alto

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy