Date Initiated by Firm |
March 03, 2011 |
Date Posted |
April 25, 2011 |
Recall Status1 |
Terminated 3 on June 19, 2012 |
Recall Number |
Z-2063-2011 |
Recall Event ID |
58246 |
510(K)Number |
K071360
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
Optical Guidance Platform is 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 |
HZ10003 HZ10151 HZ10305 HZ10507 HZ10670 HZ11015 HZ12040 HZ12090 HZ13050 HZ17041 HZ18062 HZ10008 HZ10153 HZ10311 HZ10508 HZ10674 HZ11016 HZ12041 HZ12091 HZ13052 HZ17042 HZ18066 HZ10013 HZ10154 HZ10313 HZ10509 HZ10675 HZ11017 HZ12042 HZ12092 HZ13053 HZ17043 HZ18068 HZ10014 HZ10155 HZ10316 HZ10513 HZ10676 HZ11018 HZ12043 HZ12093 HZ13054 HZ17044 HZ18069 HZ10015 HZ10157 HZ10326 HZ10528 HZ10679 HZ11019 HZ12044 HZ12094 HZ13055 HZ17046 HZ18070 HZ10017 HZ10159 HZ10330 HZ10534 HZ10681 HZ11020 HZ12045 HZ12095 HZ13056 HZ17048 HZ18076 HZ10019 HZ10165 HZ10333 HZ10537 HZ10684 HZ11021 HZ12046 HZ12096 HZ13057 HZ17049 HZ18077 HZ10023 HZ10170 HZ10335 HZ10540 HZ10685 HZ11022 HZ12047 HZ12097 HZ13058 HZ17051 HZ18079 HZ10024 HZ10172 HZ10337 HZ10541 HZ10689 HZ11023 HZ12048 HZ12098 HZ13059 HZ17057 HZ18085 HZ10025 HZ10179 HZ10343 HZ10542 HZ10693 HZ11024 HZ12049 HZ12099 HZ13060 HZ17058 HZ18088 HZ10026 HZ10181 HZ10347 HZ10544 HZ10698 HZ11025 HZ12050 HZ12100 HZ13062 HZ17059 HZ18118 HZ10027 HZ10182 HZ10352 HZ10545 HZ10700 HZ12001 HZ12051 HZ12101 HZ13063 HZ17061 HZ18120 HZ10029 HZ10183 HZ10357 HZ10547 HZ10703 HZ12002 HZ12052 HZ12102 HZ13064 HZ17062 HZ18126 HZ10044 HZ10185 HZ10368 HZ10552 HZ10706 HZ12003 HZ12054 HZ12103 HZ15006 HZ17065 HZ18131 HZ10046 HZ10187 HZ10372 HZ10553 HZ10712 HZ12004 HZ12056 HZ12104 HZ15070 HZ17067 HZ18132 HZ10048 HZ10188 HZ10376 HZ10557 HZ10715 HZ12005 HZ12057 HZ12107 HZ15118 HZ17068 HZ18134 HZ10051 HZ10190 HZ10378 HZ10560 HZ10717 HZ12006 HZ12058 HZ12108 HZ15480 HZ17069 HZ18142 HZ10052 HZ10194 HZ10379 HZ10562 HZ10722 HZ12007 HZ12059 HZ12125 HZ16006 HZ17070 HZ18143 HZ10054 HZ10196 HZ10387 HZ10568 HZ10724 HZ12008 HZ12060 HZ12126 HZ16069 HZ17071 HZ18155 HZ10055 HZ10201 HZ10392 HZ10580 HZ10728 HZ12009 HZ12061 HZ12154 HZ16070 HZ17072 HZ18175 HZ10058 HZ10203 HZ10394 HZ10584 HZ10730 HZ12010 HZ12062 HZ12188 HZ17001 HZ17074 HZ18188 HZ10061 HZ10205 HZ10398 HZ10591 HZ10731 HZ12011 HZ12063 HZ12190 HZ17002 HZ17078 HZ18193 HZ10063 HZ10209 HZ10401 HZ10592 HZ10733 HZ12012 HZ12064 HZ13006 HZ17003 HZ17079 HZ19001 HZ10065 HZ10210 HZ10403 HZ10594 HZ10737 HZ12013 HZ12065 HZ13009 HZ17006 HZ17081 HZ19003 HZ10068 HZ10220 HZ10404 HZ10598 HZ10740 HZ12015 HZ12066 HZ13013 HZ17007 HZ17106 HZ19004 HZ10070 HZ10228 HZ10408 HZ10601 HZ10743 HZ12016 HZ12067 HZ13019 HZ17010 HZ17118 HZ19005 HZ10073 HZ10237 HZ10409 HZ10607 HZ10744 HZ12018 HZ12068 HZ13020 HZ17011 HZ17126 HZ19006 HZ10076 HZ10239 HZ10411 HZ10609 HZ10759 HZ12019 HZ12069 HZ13021 HZ17012 HZ17137 HZ19007 HZ10083 HZ10240 HZ10412 HZ10611 HZ10762 HZ12020 HZ12070 HZ13022 HZ17013 HZ17142 HZ19010 HZ10084 HZ10242 HZ10425 HZ10612 HZ10764 HZ12021 HZ12071 HZ13023 HZ17016 HZ17175 HZ19012 HZ10086 HZ10245 HZ10426 HZ10613 HZ10766 HZ12022 HZ12072 HZ13024 HZ17017 HZ18001 HZ19013 HZ10088 HZ10247 HZ10430 HZ10617 HZ10771 HZ12023 HZ12073 HZ13026 HZ17018 HZ18002 HZ19014 HZ10090 HZ10249 HZ10434 HZ10620 HZ10774 HZ12024 HZ12074 HZ13029 HZ17019 HZ18004 HZ19015 HZ10092 HZ10254 HZ10438 HZ10627 HZ10776 HZ12026 HZ12075 HZ13030 HZ17020 HZ18006 HZ19017 HZ10095 HZ10257 HZ10442 HZ10629 HZ10778 HZ12027 HZ12076 HZ13031 HZ17021 HZ18013 HZ19018 HZ10098 HZ10258 HZ10450 HZ10632 HZ11001 HZ12028 HZ12077 HZ13032 HZ17023 HZ18018 HZ19019 HZ10102 HZ10260 HZ10453 HZ10640 HZ11002 HZ12029 HZ12078 HZ13038 HZ17024 HZ18020 HZ19020 HZ10108 HZ10271 HZ10460 HZ10644 HZ11003 HZ12030 HZ12080 HZ13039 HZ17027 HZ18022 HZ19022 HZ10110 HZ10273 HZ10467 HZ10646 HZ11004 HZ12031 HZ12081 HZ13041 HZ17028 HZ18024 HZ19023 HZ10116 HZ10274 HZ10479 HZ10647 HZ11005 HZ12032 HZ12082 HZ13042 HZ17030 HZ18026 HZ19025 HZ10117 HZ10283 HZ10489 HZ10649 HZ11006 HZ12033 HZ12083 HZ13043 HZ17032 HZ18035 HZ19026 HZ10121 HZ10293 HZ10493 HZ10650 HZ11007 HZ12034 HZ12084 HZ13044 HZ17034 HZ18040 HZ19028 HZ10126 HZ10294 HZ10495 HZ10652 HZ11008 HZ12035 HZ12085 HZ13045 HZ17035 HZ18041 HZ19029 HZ10138 HZ10295 HZ10496 HZ10656 HZ11010 HZ12036 HZ12086 HZ13046 HZ17036 HZ18042 HZ19033 HZ10144 HZ10297 HZ10497 HZ10659 HZ11011 HZ12037 HZ12087 HZ13047 HZ17037 HZ18043 HZ19034 HZ10146 HZ10299 HZ10500 HZ10663 HZ11013 HZ12038 HZ12088 HZ13048 HZ17039 HZ18046 HZ19035 HZ10148 HZ10303 HZ10501 HZ10665 HZ11014 HZ12039 HZ12089 HZ13049 HZ17040 HZ18048 HZ19036 HZ19040 HZ19041 HZ19043 HZ19044 HZ19045 HZ19046 HZ19051 HZ19052 HZ19053 HZ19055 HZ19056 HZ19059 HZ19060 HZ19062 HZ19065 HZ19066 HZ19068 HZ19069 HZ19071 HZ19072 HZ19076 HZ19078 HZ19079 HZ19086 HZ19087 HZ19088 HZ19089 HZ19091 HZ19095 HZ19096 HZ19098 HZ19099 HZ19104 HZ19106 HZ19109 HZ19113 HZ19114 HZ19115 HZ19117 HZ19118 HZ19119 HZ19121 HZ19125 HZ19126 HZ19128 HZ19129 HZ19130 HZ19131 HZ19133 HZ19134 HZ19135 HZ19140 HZ19141 HZ19142 HZ19143 HZ19155 HZ19158 HZ19159 HZ19162 HZ19167 HZ19170 HZ19171 HZ19172 HZ19179 HZ19186 HZ19189 HZ19190 HZ19193 HZ19194 HZ19195 HZ19201 HZ19226 HZ19227 HZ19228 HZ19229 HZ19235 HZ19236 HZ19611 HZ19926 HZ19996 HZ19997 HZ19998 |
Recalling Firm/ Manufacturer |
Varian Medical Systems, Inc. Oncology Systems 911 Hansen Way Palo Alto CA 94304-1028
|
For Additional Information Contact |
650-424-5731
|
Manufacturer Reason for Recall |
The optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations.
|
FDA Determined Cause 2 |
Software change control |
Action |
The firm, Varian, sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated March 3, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately check the Calibration timeout on their optical guidance platform. If this exceeds 24 hour, please set the factory default of 16 hours to ensure that the camera will be calibrated daily. The instructions are located in the document. The customers were also instructed to download the most recent version of the Optical Guidance Platform Instructions for Use at www.MyVarian.com or request a copy from their local Varian Customer Support District or Regional Manager. In addition, the customers were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter.
Varian is preparing a software patch which will be applied to affected units to correct this issue.
If you require further clarification, please feel free to contact your local Varian Customer Support District or Regional Manager; USA and Canada -1888-VARIAN5 (888-827-4265) or Europe- +41 41 749 8844. |
Quantity in Commerce |
599 units |
Distribution |
Worldwide distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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