510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-2224-2011

Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is...

Varian Medical Systems, Inc. / initiated 2011-03-31 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical... on . The reason FDA records is "The coolant may leak. The resulting coolant leak presents a risk of electrical shock to any person working within the protective housing". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2224-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Varian Medical Systems, Inc.
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.
Product code
IYE Accelerator, Linear, Medical
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.
Root cause tag
manufacturing process
FDA 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 in commerce
718 units
Distribution
Worldwide Distribution
Product codes and lots
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.