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Class 2 Device Recall Varian Medical Systems TrueBeam/TrueBeam STx/Edge Radiosurgical System |
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| Date Initiated by Firm |
August 20, 2018 |
| Create Date |
October 01, 2018 |
| Recall Status1 |
Terminated 3 on August 28, 2020 |
| Recall Number |
Z-0004-2019 |
| Recall Event ID |
81010 |
| 510(K)Number |
K140528 K143224
|
| Product Classification |
Accelerator, linear, medical - Product Code IYE
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| Product |
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5
EDGE Radiotherapy Delivery System version 2.0 and 2.5
Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. |
| Code Information |
TrueBeam version 2.0 Systems (software 02.00.33.02): H191007 TRUEBEAM H191017 TRUEBEAM H191024 TRUEBEAM H191025 TRUEBEAM - SO# 320239788 H191084 TRUEBEAM H191100 TRUEBEAM - SO# 320350217 H191131 TRUEBEAM H191181 TRUEBEAM - SO# 320394400 H191204 TRUEBEAM H191207 TRUEBEAM H191265 TRUEBEAM H191266 TRUEBEAM - 320442198 H191296 TRUEBEAM H191326 TRUEBEAM - 320649017 H191335 TRUEBEAM - SO# 320534442 H191349 TRUEBEAM - 320614871 H191369 TRUEBEAM - SO# 320470280 H191385 TRUEBEAM - 320612175 H191396 TRUEBEAM H191397 TRUEBEAM H191419 TRUEBEAM H191423 TRUEBEAM H191442 TRUEBEAM H191457 TRUEBEAM H191465 TRUEBEAM - SO# 320740369 H191477 TRUEBEAM H191491 TRUEBEAM - SO# 320684489 H191537 TRUEBEAM H191564 TRUEBEAM - SO# 320816541 H191613 TRUEBEAM H191616 TRUEBEAM H191623 TRUEBEAM H191627 TRUEBEAM H191642 TRUEBEAM H191647 TRUEBEAM H191654 TRUEBEAM H191670 TRUEBEAM H191676 TRUEBEAM - SO# 320886799 H191682 TRUEBEAM - 320816854 H191685 TRUEBEAM - SO# 320938575 H191699 TRUEBEAM - SO#321147839 H191707 TRUEBEAM H191714 TRUEBEAM H191716 TRUEBEAM - 320997927 H191718 TRUEBEAM - 320649017 H191723 TRUEBEAM H191724 TRUEBEAM - SO# 320889109 H191726 TRUEBEAM H191760 TRUEBEAM H191772 TRUEBEAM H191774 TRUEBEAM H192006 TRUEBEAM H192047 TRUEBEAM (2.0 SLIM) - 320997331 H192059 TRUEBEAM H192069 TRUEBEAM H192070 TRUEBEAM H192072 TRUEBEAM H192073 TRUEBEAM (2.0 SLIM) - 320936633 H192078 TRUEBEAM H192093 TRUEBEAM (2.0 SLIM) - 320997331 H192100 TRUEBEAM H192102 TRUEBEAM H192115 TRUEBEAM - SO# 320997381 H192119 TRUEBEAM - SO# 320997335 H192122 TRUEBEAM H192125 TRUEBEAM H192126 TRUEBEAM - 321107941 H192127 TRUEBEAM - 321107941 H192133 TRUEBEAM H192141 TRUEBEAM - SO# 321000817 H192168 TRUEBEAM H192193 TRUEBEAM - SO# 321119745 H192239 TRUEBEAM - SO# 321068552 H192243 TRUEBEAM - SO# 321000799 H192252 TRUEBEAM - SO# 320997335 H192267 TRUEBEAM - SO# 321156432 H192269 TRUEBEAM - SO# 321156441 H192270 TRUEBEAM - SO# 321156445 H192271 TRUEBEAM - SO# 321156448 H192281 TRUEBEAM H192289 TRUEBEAM H192294 TRUEBEAM H192321 TRUEBEAM - SO# 320997325 H192391 TRUEBEAM H191204 TRUEBEAM H191266 TRUEBEAM - 320442198 H191396 TRUEBEAM H191397 TRUEBEAM H191423 TRUEBEAM H192127 TRUEBEAM - 321107941 TrueBeam version 2.0MR1 Systems (software 02.00.33.04): H191197 TRUEBEAM H191253 TRUEBEAM H191306 TRUEBEAM - 320633051 H191639 TRUEBEAM - 320887142 H191709 TRUEBEAM H192065 TRUEBEAM H192110 TRUEBEAM H192136 TRUEBEAM - SO# 320943436 H192189 TRUEBEAM - SO# 320943426 H192283 TRUEBEAM TrueBeam version 2.5 Systems (software 02.05.13.03): H191047 TRUEBEAM - SO# 320269463 H191082 TRUEBEAM - SO# 320349613 H191120 TRUEBEAM - SO# 320390413 H191139 TRUEBEAM H191147 TRUEBEAM H191149 TRUEBEAM - SO# 320450624 H191163 TRUEBEAM - SO# 320395997 H191176 TRUEBEAM - SO# 320177035 H191241 TRUEBEAM - SO# 320443663 H191264 TRUEBEAM - 320471285 H191276 TRUEBEAM H191292 TRUEBEAM H191293 TRUEBEAM H191301 TRUEBEAM H191309 TRUEBEAM H191311 TRUEBEAM H191342 TRUEBEAM - SO# 320634237 H191355 TRUEBEAM H191371 TRUEBEAM - SO# 320538065 H191372 TRUEBEAM H191373 TRUEBEAM - SO# 320443408 H191375 TRUEBEAM - SO# 320393735 H191384 TRUEBEAM H191434 TRUEBEAM H191444 TRUEBEAM H191451 TRUEBEAM - SO# 320634237 H191466 TRUEBEAM H191480 TRUEBEAM H191494 TRUEBEAM - SO# 320515943 H191506 TRUEBEAM - SO# 320589021 H191523 TRUEBEAM H191524 TRUEBEAM H191539 TRUEBEAM H191551 TRUEBEAM H191556 TRUEBEAM - SO# 320589009 H191565 TRUEBEAM H191590 TRUEBEAM - 320785566 H191599 TRUEBEAM - SO# 320634826 H191630 TRUEBEAM - SO# 320836168 H191657 TRUEBEAM - SO# 320734678 H191697 TRUEBEAM H191770 TRUEBEAM - 320890147 H191771 TRUEBEAM - 321166276 H192044 TRUEBEAM H192152 TRUEBEAM - SO# 320941465 H192177 TRUEBEAM H192178 TRUEBEAM H192257 TRUEBEAM - 320942552 H192266 TRUEBEAM - SO# 321111637 H192299 TRUEBEAM - SO# 320889915 H192313 TRUEBEAM H192315 TRUEBEAM H192342 TRUEBEAM H192360 TRUEBEAM H192378 TRUEBEAM H192386 TRUEBEAM H192388 TRUEBEAM H192411 TRUEBEAM H192422 TRUEBEAM H192451 TRUEBEAM H192453 TRUEBEAM - SO# 321202021 H192456 TRUEBEAM H192458 TRUEBEAM H192473 TRUEBEAM TrueBeam version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H191059 TRUEBEAM - SO# 320264430 H191075 TRUEBEAM - SO# 320337040 H191095 TRUEBEAM H191115 TRUEBEAM - SO# 320396943 H191117 TRUEBEAM H191166 TRUEBEAM - SO# 320351677 H191194 TRUEBEAM H191250 TRUEBEAM H191285 TRUEBEAM H191291 TRUEBEAM H191320 TRUEBEAM H191322 TRUEBEAM H191332 TRUEBEAM H191333 TRUEBEAM H191356 TRUEBEAM - SO# 320471682 H191417 TRUEBEAM - SO# 320585415 H191446 TRUEBEAM H191473 TRUEBEAM H191508 TRUEBEAM H191588 TRUEBEAM H191591 TRUEBEAM H191606 TRUEBEAM H191610 TRUEBEAM - SO# 320815300 H191619 TRUEBEAM H191644 TRUEBEAM - SO# 320889534 H191646 TRUEBEAM H191649 TRUEBEAM H191650 TRUEBEAM H191652 TRUEBEAM H191663 TRUEBEAM - 320810805 H191669 TRUEBEAM - 320852536 H191673 TRUEBEAM - SO# 320836166 H191675 TRUEBEAM - SO# 320386532 H191690 TRUEBEAM H191711 TRUEBEAM H191749 TRUEBEAM H191751 TRUEBEAM - 320890150 H191752 TRUEBEAM H191753 TRUEBEAM H191758 TRUEBEAM H191759 TRUEBEAM H191764 TRUEBEAM H191765 TRUEBEAM H191767 TRUEBEAM H191768 TRUEBEAM H191773 TRUEBEAM H192076 TRUEBEAM - 320993070 H192086 TRUEBEAM H192087 TRUEBEAM - 320763229 H192089 TRUEBEAM H192098 TRUEBEAM - 321062057 H192114 TRUEBEAM H192131 TRUEBEAM H192138 TRUEBEAM H192144 TRUEBEAM - SO# 321023744 H192146 TRUEBEAM - 321108755 H192163 TRUEBEAM - 320982563 H192166 TRUEBEAM H192169 TRUEBEAM H192194 TRUEBEAM H192200 TRUEBEAM H192201 TRUEBEAM - SO# 320880995 H192202 TRUEBEAM - SO# 320880995 H192225 TRUEBEAM H192241 TRUEBEAM - 321163414 H192244 TRUEBEAM H192287 TRUEBEAM H192310 TRUEBEAM - SO# 321105475 H192323 TRUEBEAM - SO# 321000772 H192324 TRUEBEAM - SO# 321111621 H192325 TRUEBEAM - SO# 321223566 H192327 TRUEBEAM H192329 TRUEBEAM - SO# 321223566 H192341 TRUEBEAM - SO# 321223566 H192343 TRUEBEAM H192348 TRUEBEAM H192349 TRUEBEAM H192351 TRUEBEAM H192352 TRUEBEAM - 320924066 H192358 TRUEBEAM H192365 TRUEBEAM H192375 TRUEBEAM - 320630873 H192376 TRUEBEAM H192377 TRUEBEAM - 320942521 H192379 TRUEBEAM H192381 TRUEBEAM H192390 TRUEBEAM - SO# 321268743 H192392 TRUEBEAM H192405 TRUEBEAM H192410 TRUEBEAM H192417 TRUEBEAM H192418 TRUEBEAM H192438 TRUEBEAM - SO# 321111674 H192439 TRUEBEAM H192441 TRUEBEAM - SO# 321221591 H192444 TRUEBEAM H192457 TRUEBEAM H192466 TRUEBEAM H192474 TRUEBEAM - SO# 321051592 H192483 TRUEBEAM H192486 TRUEBEAM H192496 TRUEBEAM H192497 TRUEBEAM H192499 TRUEBEAM H192500 TRUEBEAM H192506 TRUEBEAM H192520 TRUEBEAM - SO# 321165761 H192527 TRUEBEAM H192532 TRUEBEAM H192533 TRUEBEAM H192537 TRUEBEAM H192541 TRUEBEAM - SO# 321209716 H192548 TRUEBEAM H192550 TRUEBEAM H192558 TRUEBEAM H192560 TRUEBEAM - SO# 321275781 H192565 TRUEBEAM H192567 TRUEBEAM H192580 TRUEBEAM - SO# 321376439 H192583 TRUEBEAM - SO# 321108427 H192590 TRUEBEAM - 321380296 H192595 TRUEBEAM H192597 TRUEBEAM - SO# 321328946 H192605 TRUEBEAM H192610 TRUEBEAM - SO# 321275873 H192614 TRUEBEAM H192616 TRUEBEAM - SO# 321221611 H192630 TRUEBEAM - SO# 321373712 H192631 TRUEBEAM - SO# 321373712 H192632 TRUEBEAM H192638 TRUEBEAM - SO# 321164402 H192645 TRUEBEAM - SO#321382335 H192648 TRUEBEAM H192652 TRUEBEAM H192654 TRUEBEAM H192658 TRUEBEAM H192668 TRUEBEAM - 320890159 H192671 TRUEBEAM - SO#320997325 H192675 TRUEBEAM - SO# 321278187 H192679 TRUEBEAM - 320889323 H192680 TRUEBEAM H192681 TRUEBEAM H192693 TRUEBEAM H192701 TRUEBEAM - 321330605 H192703 TRUEBEAM H192710 TRUEBEAM H192759 TRUEBEAM - SO# 321222124 H192760 TRUEBEAM - 321393817 H192768 TRUEBEAM H192787 TRUEBEAM H192794 TRUEBEAM H192799 TRUEBEAM TrueBeam Stx version 2.0 Systems (software 02.00.33.03): H191133 TRUEBEAM STX H191289 TRUEBEAM STX H191338 TRUEBEAM STX H191418 TRUEBEAM STX H191426 TRUEBEAM STX - 320715156 H191429 TRUEBEAM STX H191458 TRUEBEAM STX H191482 TRUEBEAM STX H191594 TRUEBEAM STX - SO# 321197174 (Ugd) H191656 TRUEBEAM STX - SO# 320883795 H191708 TRUEBEAM STX H191719 TRUEBEAM STX H191725 TRUEBEAM STX H191750 TRUEBEAM STX H192018 TRUEBEAM STX EDGE H192048 TRUEBEAM STX H192055 TRUEBEAM STX H192215 TRUEBEAM STX H191430 TRUEBEAM STX H191476 TRUEBEAM STX - SO#321792139 upg H191531 TRUEBEAM STX TrueBeam STx version 2.0MR1 Systems (software 02.00.33.04): H191035 TRUEBEAM STX H191738 TRUEBEAM STX - SO# 320974437 TrueBeam STx version 2.5 Systems (software 02.05.13.03): H191028 TRUEBEAM STX - SO# 320175149 H191033 TRUEBEAM STX H191038 TRUEBEAM STX - SO# 320303883 H191068 TRUEBEAM STX - 320307189 H191158 TRUEBEAM STX - 320488589 H191217 TRUEBEAM STX H191315 TRUEBEAM STX H192151 TRUEBEAM STX - SO# 320943434 TrueBeam STx version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H191153 TRUEBEAM STX - SO# 320327517 H191183 TRUEBEAM STX - SO# 320442922 H191196 TRUEBEAM STX H191274 TRUEBEAM STX H191318 TRUEBEAM STX H191321 TRUEBEAM STX H191387 TRUEBEAM STX H191448 TRUEBEAM STX H191450 TRUEBEAM STX - SO# 320686322 H191525 TRUEBEAM STX - SO# 320588995 H191597 TRUEBEAM STX H191637 TRUEBEAM STX H191684 TRUEBEAM STX H191739 TRUEBEAM STX H192021 TRUEBEAM STX - SO# 320589101 H192234 TRUEBEAM STX H192357 TRUEBEAM STX H192407 TRUEBEAM STX H192493 TRUEBEAM STX H192494 TRUEBEAM STX H192498 TRUEBEAM STX 321109749 H192507 TRUEBEAM STX 321331339 H192566 TRUEBEAM STX 321199361 H192598 TRUEBEAM STX - SO#321109587 H192667 TRUEBEAM STX 321070912 H192749 TRUEBEAM STX 321294620 H192782 TRUEBEAM STX 320997611 H192785 TRUEBEAM STX 320997614 H192801 TRUEBEAM STX H192807 TRUEBEAM STX 320997610 TrueBeam Edge version 2.0 Systems (software 02.00.22.02): H192005 TRUEBEAM EDGE - 320868916 H192097 TRUEBEAM EDGE - 321103831 H192620 TRUEBEAM EDGE - SO#321382807 TrueBeam Edge version 2.0MR1 Systems (software 02.00.33.04): H192401 TRUEBEAM EDGE H192431 TRUEBEAM EDGE - SO#321276692 TrueBeam Edge version 2.5 Systems (software 02.05.13.03): H192447 TRUEBEAM EDGE TrueBeam Edge version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192124 TRUEBEAM EDGE - 321108891 H192301 TRUEBEAM EDGE H192435 TRUEBEAM EDGE¿ H192484 TRUEBEAM EDGE - SO# 321167229 H192578 TRUEBEAM EDGE H192691 TRUEBEAM EDGE - 321590884 H192709 TRUEBEAM EDGE¿ H192804 TRUEBEAM EDGE - 321549992 H192821 TRUEBEAM EDGE - 321544716 H192833 TRUEBEAM EDGE **************************************** TrueBeam Systems (software 02.00.29.03): H191204 TRUEBEAM H191266 TRUEBEAM - 320442198 H191396 TRUEBEAM H191397 TRUEBEAM H191423 TRUEBEAM H192127 TRUEBEAM - 321107941 TrueBeam STx (software 02.00.29.03): H191430 TRUEBEAM STX H191476 TRUEBEAM STX - SO#321792139 upg H191531 TRUEBEAM STX Varian Product Code family H19, which includes TrueBeam, TrueBeam STx, VitalBeam and EDGE. |
Recalling Firm/
Manufacturer |
Varian Medical Systems
3100 Hansen Way
Palo Alto CA 94304-1030
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Manufacturer Reason
for Recall |
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
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FDA Determined
Cause 2 |
Software design |
| Action |
On 08/20/2018 the firm sent an URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE to customer via courier service (US and Canada via FedEx on 8/23/2018, and Rest of World via third party courier on 8/24/2018) informing them the firm had received reports of an anomaly that can result in a treatment without intended gating, and that this issue occurs when a patient planned with gating is treated on more than one system. Customers were advised, for treatment plans with intended gating, the firm recommends users monitor and pay attention to the system status message. When a patient with a gated treatment plan is moved to a second system, users must verify that intending gating was not overridden. If gating is overridden, users should reselect it from the Tools menu. The customer were informed that they will be contacted by a Customer Service Representative to schedule upgrade to the correction when available and if they have any questions regarding selecting gating from the Tools menu to contact customer support.
Help Desk Contact Information:
Phone: +1.888.827.4265
Email: support @varian.com
In addition, the URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE, informs the customers to:
1) Please retain a copy of this document along with your most current product labeling.
2) Advise the appropriate personnel working in your radiotherapy department of the content of this letter.
3) For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com.
and In order to satisfy regulatory requirements, we request that you complete the attached Recall Return Response form provided. Kindly return the completed form to returnresponse@varian.com. |
| Quantity in Commerce |
387 |
| Distribution |
Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of :
Algeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom |
| 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.
510(K)s with Product Code = IYE and Original Applicant = Varian Medical Systems, Inc.
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