FDAFDA · Food and drugs·Recall number Z-1163-2013
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Published May 1, 2013 · Recall initiated: March 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Option. While operating with the 6-dot marker block, this version of RPM Gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Distributor
- Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.
- Lot
- CODES: HS00017 HS00366 HS00611 HS00804 HS01060 HS01256 HS01451 HS01662 HS01863 HS02024 HS02215 HS02371 HS02539 HS00018 HS00371 HS00615 HS00805 HS01061 HS01260 HS01456 HS01664 HS01872 HS02035 HS02239 HS02373 HS02542 HS00025 HS00378 HS00618 HS00806 HS01062 HS01265 HSOI459 HSOI667 HSOI875 HS02040 HS02240 HS02376 HS02545 HS00026 HS00384 HS00619 HS00807 HSOI063 HSOI269 HSOI460 HSOI671 HSOI876 HS02043 HS02242 HS02377 HS02548 HS00031 HS00385 HS00624 HS00811 HSOI066 HS01270 HSOI462 HSOI674 HSOI877 HS02048 HS02245 HS02380 HS02SSI HS00032 HS00392 HS00628 HS00813 HS01069 HSOI281 HS01463 HSOI675 HSOI878 HS02053 HS02250 HS02381 HS02553 HS00035 HS00393 HS00630 HS00814 HS01071 HSOI282 HS01466 HS01676 HS01883 HS020SS HS022Sl HS02383 HS02554 HS00036 HS00396 HS00634 HSOOSIS HS01080 HS01283 HS0147l HS01678 HS01885 HS02059 HS02253 HS02384 HS02SSS HS00037 HS00398 HS00636 HS00818 HSOIOSS HS01285 HS01480 HS01685 HS01886 HS02068 HS02256 HS02389 HS02562 HS00038 HS00408 HS00638 HS00827 HS01090 HS01291 HS01489 HS01686 HS01888 HS02070 HS02262 HS02392 HS02565 HS00039 HS00410 HS00639 HS00829 HS01093 HS01296 HSOI490 HS01694 HS01889 HS02072 HS02263 HS02395 HS02566 HS00043 HS00420 HS00640 HS00843 HS01094 HS01299 HSOI498 HS01696 HS01890 HS02080 HS02267 HS02397 HS02567 h500044 HS00422 HS0064l HS008Sl HSOllOO HS01303 HS01499 HS01697 HS01893 HS02083 HS02268 HS02399 HS02569 HS00049 HS00433 HS00643 HS00856 HSOIIOS HS01307 HSOISOO HS01698 HS01895 HS02085 HS02269 HS02401 HS02573 HSOOOSO HS00434 HS00644 HS00873 HSOI106 HS01308 HSOIS03 HS01700 HS01896 HS02087 HS02278 HS02403 HS02574 HS00073 HS00435 HS00646 HS00879 HS01108 HS013ll HSOISIO HS01704 HS01897 HS02088 HS02279 HS02406 HS02575 HS00074 HS00440 HS00649 HS00881 HS01109 HS01313 HSOISll HS01707 HS01900 HS02090 HS02280 HS02408 HS02576 HS00075 HS00443 HS00654 HS00890 HSOI113 HS01314 HSOISIS HS01708 HS01902 HS02097 HS02282 HS02409 HS02584 HS00077 HS00452 HS00664 HS00892 HSOlll9 HS01320 HSOIS25 HS01709 HS01908 HS02099 HS02283 HS024ll HS02586 HS00078 HS004SS h500666 HS00897 HSOII20 HS01324 HSOIS30 HS01710 HS01912 HS02100 HS02284 HS02418 HS02587 HS00086 HS00456 HS00669 HS00899 HSOll2l HSOI327 HS01533 HS017ll HS01913 HS02102 HS02286 HS02419 HS02596 HS00087 HS00458 HS00670 HS00900 HSOll26 HS01331 HSOIS35 HS01714 HSOI914 HS02ll4 HS02289 HS02420 HS02598 HS00088 HS00465 HS00671 HS0090l HS01128 HS01332 HSOIS39 HSOI718 HS01921 HS02116 HS02292 HS02424 HS02600 HS00089 HS00466 HS00673 HS00914 HS01130 HS01335 HSOIS41 HS01721 HS01940 HS02117 HS02293 HS02425 HS02604 HS00097 HS00467 HS00679 HS00915 HS0113l HS01338 HSOIS44 HSOI722 HS01943 HS02118 HS02294 HS02427 HS02607 HSOOIOI HS00468 HS00682 HS00927 HS01132 HS01340 HSOIS45 HSOI732 HS01944 HS0212l HS02300 HS0243l HS02612 HS00102 HS00470 HS00684 HS00930 HS01135 HSOI34l HSOIS47 HS01733 HS01948 HS02126 HS02301 HS02433 HS02613 HS00108 HS00473 HS00687 HS00933 HS01140 HSOI344 HSOIS48 HS01735 HS019Sl HS02128 HS02306 HS02440 HS02616 HSOOI20 HS00479 HS00689 HS00942 HS01141 HSOI346 HSOISSl HS01737 HS01953 HS02135 HS02309 HS02441 HS02618 HS0012l HS00481 HS00693 HS00949 HS01142 HS01350 HSOISS4 HS01744 HS019SS HS02136 HS023ll HS02442 HS02620 HSOOI30 HS00487 HS00695 HS00950 HSOll46 HS01360 HSOIS76 HS01747 HSOI956 HS02138 HS02321 HS02461 HS02621 HSOOIS7 HS00491 HS00697 HS00951 HS01147 HSOI362 HSOIS80 HS017SS HS01957 HS02140 HS02322 HS02463 HS02636 HSOOI64 HS00492 HS00703 HS00958 HSOllSl HS01372 HSOIS82 HS01756 HS01958 HS02141 HS02327 HS02464 HS02638 HS00188 HSOOS02 HS00710 HS00959 HS01160 HSOI374 HSOIS84 HS01759 HS01964 HS02146 HS02331 HS02467 HS02640 HS0019l HSOOSOS HS00715 HS00960 HSOI166 HS01379 HSOIS89 HS01763 HS01971 HS02152 HS02332 HS02474 HS02646 h500192 HSOOS24 HS00717 HS00962 HS01170 HSOI380 HSOIS92 HS01766 HS01972 HS02153 HS02333 HS02478 HS02649 HSOOI93 HSOOS34 HS00722 HS00963 HS01173 HSOI384 HSOIS93 HS01768 HS01973 HS02154 HS02335 HS02481 HS02652 h500208 HSOOS36 HS00725 HS00964 HSOll74 HS01385 H501598 H501776 H501974 H502155 H502337 H502484 H502653
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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