Events

Recall of Device Recall Clinac

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58558
  • Event Risk Class
    Class 2
  • Event Number
    Z-2224-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99592
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • Reason
    The coolant may leak. the resulting coolant leak presents a risk of electrical shock to any person working within the protective housing.
  • 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.

Device

Device Recall Clinac
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA