Class 2 Device Recall Clinac

• Date Initiated by Firm: March 31, 2011
• Date Posted: May 20, 2011
• Recall Status: Terminated on March 13, 2012
• Recall Number: Z-2224-2011
• Recall Event ID: 58558
• 510(K)Number: K100890
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA; ; Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
• Code Information: LIST OF SERIAL NUMBERS H140126 ,H140869 ,H140919 ,H294300 ,H294348 ,H294396 ,H294443 ,H294494 ,H294541 ,H294596 ,H294644 ,H140151 ,H140870 ,H140920 ,H294301 ,H294349 ,H294397 ,H294444 ,H294495 ,H294542 ,H294597 ,H294645 ,H140820 ,H140871 ,H140921 ,H294302 ,H294350 ,H294398 ,H294445 ,H294496 ,H294543 ,H294598 ,H294646 ,H140825 ,H140872 ,H191001 ,H294303 ,H294351 ,H294399 ,H294446 ,H294497 ,H294544 ,H294599 ,H294647 ,H140826 ,H140873 ,H191002 ,H294304 ,H294352 ,H294400 ,H294447 ,H294498 ,H294545 ,H294600 ,H294648 ,H140827 ,H140874 ,H191003 ,H294305 ,H294353 ,H294401 ,H294448 ,H294499 ,H294546 ,H294601 ,H294649 ,H140828 ,H140875 ,H191005 ,H294306 ,H294354 ,H294402 ,H294449 ,H294500 ,H294547 ,H294602 ,H294650 ,H140829 ,H140876 ,H191006 ,H294307 ,H294355 ,H294403 ,H294450 ,H294501 ,H294548 ,H294603 ,H294651 ,H140830 ,H140877 ,H191007 ,H294308 ,H294356 ,H294404 ,H294451 ,H294502 ,H294549 ,H294604 ,H294652 ,H140831 ,H140878 ,H290168 ,H294309 ,H294357 ,H294405 ,H294452 ,H294503 ,H294550 ,H294605 ,H294653 ,H140832 ,H140879 ,H290246 ,H294310 ,H294358 ,H294406 ,H294454 ,H294504 ,H294551 ,H294606 ,H294654 ,H140833 ,H140881 ,H290282 ,H294311 ,H294359 ,H294407 ,H294458 ,H294505 ,H294552 ,H294607 ,H294655 ,H140834 ,H140882 ,H291040 ,H294312 ,H294360 ,H294408 ,H294459 ,H294506 ,H294553 ,H294608 ,H294656 ,H140835 ,H140883 ,H293427 ,H294313 ,H294361 ,H294409 ,H294460 ,H294507 ,H294554 ,H294610 ,H294657 ,H140836 ,H140884 ,H293608 ,H294314 ,H294362 ,H294410 ,H294461 ,H294508 ,H294555 ,H294611 ,H294658 ,H140837 ,H140886 ,H293884 ,H294315 ,H294363 ,H294411 ,H294462 ,H294509 ,H294556 ,H294612 ,H294659 ,H140838 ,H140887 ,H293885 ,H294316 ,H294364 ,H294412 ,H294463 ,H294510 ,H294557 ,H294613 ,H294660 ,H140839 ,H140888 ,H294043 ,H294317 ,H294365 ,H294413 ,H294464 ,H294511 ,H294564 ,H294614 ,H294661 ,H140840 ,H140889 ,H294084 ,H294318 ,H294366 ,H294414 ,H294465 ,H294512 ,H294565 ,H294615 ,H294662 ,H140841 ,H140890 ,H294088 ,H294319 ,H294367 ,H294415 ,H294466 ,H294513 ,H294567 ,H294616 ,H294663 ,H140842 ,H140891 ,H294154 ,H294320 ,H294368 ,H294416 ,H294467 ,H294514 ,H294568 ,H294617 ,H294664 ,H140843 ,H140892 ,H294206 ,H294321 ,H294369 ,H294417 ,H294468 ,H294515 ,H294569 ,H294618 ,H294665 ,H140844 ,H140893 ,H294274 ,H294322 ,H294370 ,H294418 ,H294469 ,H294516 ,H294570 ,H294619 ,H294666 ,H140845 ,H140895 ,H294275 ,H294323 ,H294371 ,H294419 ,H294470 ,H294517 ,H294571 ,H294620 ,H294667 ,H140846 ,H140896 ,H294276 ,H294324 ,H294372 ,H294420 ,H294471 ,H294518 ,H294572 ,H294621 ,H294668 ,H140847 ,H140897 ,H294277 ,H294325 ,H294373 ,H294421 ,H294472 ,H294519 ,H294573 ,H294622 ,H294669 ,H140848 ,H140898 ,H294278 ,H294326 ,H294374 ,H294422 ,H294473 ,H294520 ,H294574 ,H294623 ,H294670 ,H140849 ,H140899 ,H294279 ,H294327 ,H294376 ,H294423 ,H294474 ,H294521 ,H294575 ,H294624 ,H294671 ,H140850 ,H140900 ,H294280 ,H294328 ,H294377 ,H294424 ,H294475 ,H294522 ,H294576 ,H294625 ,H294672 ,H140851 ,H140901 ,H294281 ,H294329 ,H294378 ,H294425 ,H294476 ,H294523 ,H294577 ,H294626 ,H294673 ,H140852 ,H140902 ,H294283 ,H294330 ,H294379 ,H294426 ,H294477 ,H294524 ,H294579 ,H294627 ,H294674 ,H140853 ,H140903 ,H294284 ,H294331 ,H294380 ,H294427 ,H294478 ,H294525 ,H294580 ,H294628 ,H294675 ,H140854 ,H140904 ,H294285 ,H294332 ,H294381 ,H294428 ,H294479 ,H294526 ,H294581 ,H294629 ,H294676 ,H140855 ,H140905 ,H294286 ,H294333 ,H294382 ,H294429 ,H294480 ,H294527 ,H294582 ,H294630 ,H294677 ,H140856 ,H140906 ,H294287 ,H294334 ,H294383 ,H294430 ,H294481 ,H294528 ,H294583 ,H294631 ,H294678 ,H140857 ,H140907 ,H294288 ,H294335 ,H294384 ,H294431 ,H294482 ,H294529 ,H294584 ,H294632 ,H294679 ,H140858 ,H140908 ,H294289 ,H294336 ,H294385 ,H294432 ,H294483 ,H294530 ,H294585 ,H294633 ,H294680 ,H140859 ,H140909 ,H294290 ,H294337 ,H294386 ,H294433 ,H294484 ,H294531 ,H294586 ,H294634 ,H294681 ,H140860 ,H140910 ,H294291 ,H294338 ,H294387 ,H294434 ,H294485 ,H294532 ,H294587 ,H294635 ,H294682 ,H140861 ,H140911 ,H294292 ,H294339 ,H294388 ,H294435 ,H294486 ,H294533 ,H294588 ,H294636 ,H294683 ,H140862 ,H140912 ,H294293 ,H294340 ,H294389 ,H294436 ,H294487 ,H294534 ,H294589 ,H294637 ,H294684 ,H140863 ,H140913 ,H294294 ,H294341 ,H294390 ,H294437 ,H294488 ,H294535 ,H294590 ,H294638 ,H294685 ,H140864 ,H140914 ,H294295 ,H294342 ,H294391 ,H294438 ,H294489 ,H294536 ,H294591 ,H294639 ,H294686 ,H140865 ,H140915 ,H294296 ,H294343 ,H294392 ,H294439 ,H294490 ,H294537 ,H294592 ,H294640 ,H294687 ,H140866 ,H140916 ,H294297 ,H294345 ,H294393 ,H294440 ,H294491 ,H294538 ,H294593 ,H294641 ,H294688 ,H140867 ,H140917 ,H294298 ,H294346 ,H294394 ,H294441 ,H294492 ,H294539 ,H294594, H294642, H294689, H140868, H140918, H294299, H294347, H294395, H294442, H294493, H294540, H294595, H294643, H294690, H294691, H294718, H294747, H294774, H294802, H294831, H294858, H294885, H294692, H294719, H294748, H294775, H294803, H294832, H294859, H294886, H294693, H294720, H294749, H294776, H294804, H294833, H294860, H294887, H294694, H294721, H294750, H294777, H294806, H294834, H294861, H294888, H294695, H294723, H294751, H294778, H294807, H294835, H294862, H294889, H294696, H294724, H294752, H294779, H294808, H294836, H294863,H294890, H294697, H294726, H294753, H294780, H294809, H294837, H294864, H294891, H294698, H294727, H294754, H294781, H294810, H294838, H294865, H294892, H294699, H294728, H294755, H294782, H294811, H294839, H294866, H294894, H294700, H294729, H294756, H294783, H294812, H294840, H294867, H294895, H294701, H294730, H294757, H294784, H294813, H294841, H294868, H294896, H294702, H294731, H294758, H294786, H294814, H294842, H294869, H294898, H294704, H294732, H294759, H294787, H294815, H294843, H294870, H294899, H294705, H294733, H294760, H294788, H294816, H294844, H294871, H294900, H294706, H294734, H294761, H294789, H294817, H294845, H294872, H294901, H294707, H294735, H294762, H294790, H294818, H294846, H294874, H294902, H294708, H294736, H294763, H294792, H294820, H294847, H294875, H294904, H294709, H294737, H294764, H294793, H294821, H294848, H294876,H294965, H294710, H294738, H294765, H294794, H294822, H294850, H294877, H294972, H294711, H294739, H294766, H294795, H294823, H294851, H294878, H294712, H294740, H294768, H294796, H294824, H294852, H294879, H294713, H294742, H294769, H294797, H294825, H294853, H294880, H294714, H294743, H294770, H294798, H294826, H294854, H294881, H294715, H294744, H294771, H294799, H294827, H294855, H294882, H294716, H294745, H294772, H294800, H294829, H29485, H294883, H294717, H294746, H294773, H294801, H294830, H294857, and H294884.
• 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: The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.
• FDA Determined Cause: Process design
• Action: On 3/31/2011, all consignees were notified via an Urgent Medical Device Correction letter and on-site visit by the firm's sales representative, informing them of the affected products, the issue, and recommended actions. If non-Varian personnel service the device, then they should have been immediately notified of the content of the letter. Anyone who performs work on the device should exercise extreme care to identify any possible coolant leak and immediately locate and correct the source of the leak. Customers were to immediately notify Varian Service or their internal service personnel of any coolant leakage. Varian was to contact customers to arrange for inspection if one had not been performed. The appropriate personnel should have been advised of the content of the letter. If further clarification was needed, customers were to contact their local Varian Customer Support.
• Quantity in Commerce: 718 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