Varian Medical Systems, Inc. Oncology Systems: 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.

Recall number

Z-2224-2011

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

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.

Status

Terminated

Initiated

2011-03-31

Posted

2011-05-20

Terminated

2012-03-13

Reason

The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.

Root 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

718 units

Distribution

Worldwide Distribution

Lot, serial or model codes

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.

510(k) numbers

["K100890"]

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

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