Reported May 1, 2013 · Terminated
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM…
Varian Medical Systems, Inc. Oncology Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. Oncology Systems · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option
- Model NumberHS2
- Product UsageThe RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion
- Lot codes and dates
- CODESHSOOSIS
94 of 94 codes
HS00017HS00366HS00611HS00804HS01060HS01256HS01451HS01662HS01863HS02024HS02215HS02371HS02539HS00018HS00371HS00615HS00805HS01061HS01260HS01456HS01664HS01872HS02035HS02239HS02373HS02542HS00025HS00378HS00618HS00806HS01062HS01265HSOI459HSOI667HSOI875HS02040HS02240HS02376HS02545HS00026HS00384HS00619HS00807HSOI063HSOI269HSOI460HSOI671HSOI876HS02043HS02242HS02377HS02548HS00031HS00385HS00624HS00811HSOI066HS01270HSOI462HSOI674
HSOIOSSHS01080HS01283HS0147lHS01678HS01885HS02059HS02253HS02384HS02SSSHS00037HS00398HS00636HS00818
HSOllOOHS01285HS01480HS01685HS01886HS02068HS02256HS02389HS02562HS00038HS00408HS00638HS00827HS01090HS01291HS01489HS01686HS01888HS02070HS02262HS02392HS02565HS00039HS00410HS00639HS00829HS01093HS01296HSOI490HS01694HS01889HS02072HS02263HS02395HS02566HS00043HS00420HS00640HS00843HS01094HS01299HSOI498HS01696HS01890HS02080HS02267HS02397HS02567h500044HS00422HS0064lHS008Sl
HSOIIOS HS01307 HSOISOO HS01698 HS01895 HS02085 HS02269 HS02401 HS02573 HSOOOSOHS01303HS01499HS01697HS01893HS02083HS02268HS02399HS02569HS00049HS00433HS00643HS00856
HSOISIOHS00434HS00644HS00873HSOI106HS01308HSOIS03HS01700HS01896HS02087HS02278HS02403HS02574HS00073HS00435HS00646HS00879HS01108HS013ll
HSOISllHS01704HS01897HS02088HS02279HS02406HS02575HS00074HS00440HS00649HS00881HS01109HS01313
HSOISISHS01707HS01900HS02090HS02280HS02408HS02576HS00075HS00443HS00654HS00890HSOI113HS01314
HSOOIOI97 of 97 codes
HS01708HS01902HS02097HS02282HS02409HS02584HS00077HS00452HS00664HS00892HSOlll9HS01320HSOIS25HS01709HS01908HS02099HS02283HS024llHS02586HS00078HS004SSh500666HS00897HSOII20HS01324HSOIS30HS01710HS01912HS02100HS02284HS02418HS02587HS00086HS00456HS00669HS00899HSOll2lHSOI327HS01533HS017llHS01913HS02102HS02286HS02419HS02596HS00087HS00458HS00670HS00900HSOll26HS01331HSOIS35HS01714HSOI914HS02ll4HS02289HS02420HS02598HS00088HS00465
HSOISSlHS00468HS00682HS00927HS01132HS01340HSOIS45HSOI732HS01944HS0212lHS02300HS0243lHS02612HS00102HS00470HS00684HS00930HS01135HSOI34lHSOIS47HS01733HS01948HS02126HS02301HS02433HS02613HS00108HS00473HS00687HS00933HS01140HSOI344HSOIS48HS01735HS019SlHS02128HS02306HS02440HS02616HSOOI20HS00479HS00689HS00942HS01141HSOI346
HSOllSlHS01737HS01953HS02135HS02309HS02441HS02618HS0012lHS00481HS00693HS00949HS01142HS01350HSOISS4HS01744HS019SSHS02136HS023llHS02442HS02620HSOOI30HS00487HS00695HS00950HSOll46HS01360HSOIS76HS01747HSOI956HS02138HS02321HS02461HS02621HSOOIS7HS00491HS00697HS00951HS01147HSOI362HSOIS80HS017SSHS01957HS02140HS02322HS02463HS02636HSOOI64HS00492HS00703HS00958
HSOOSOSHS01372HSOIS82HS01756HS01958HS02141HS02327HS02464HS02638HS00188HSOOS02HS00710HS00959HS01160HSOI374HSOIS84HS01759HS01964HS02146HS02331HS02467HS02640HS0019l
HSOOSSO116 of 116 codes
HS00715HS00960HSOI166HS01379HSOIS89HS01763HS01971HS02152HS02332HS02474HS02646h500192HSOOS24HS00717HS00962HS01170HSOI380HSOIS92HS01766HS01972HS02153HS02333HS02478HS02649HSOOI93HSOOS34HS00722HS00963HS01173HSOI384HSOIS93HS01768HS01973HS02154HS02335HS02481HS02652h500208HSOOS36HS00725HS00964HSOll74HS01385H501598H501776H501974H502155H502337H502484H502653HS00213H500538HS00727HS00968H501175H501386HS01600HS01780H501977HS02163
HSOIOOSHS00736HS00991HS01198HS01396H501610H501797HS01988HS02171HS02347HS02SOSHS02666HS00283HS00551HS00749HSOI002H501202H501403H501612H501800H501990H502172HS02348H502506H502672HS00286HSOOSS7HS007Sl
HSOIOIIHS01203HSOI410H501616HS01804H501992H502173HS02350H502509HS02673HS00287H500561HS00753HS01009HS01210HSOI417HS01617H5018llH501995H502174H502352H502510HS02674HS00288H500563HS00754
HSOIOISHS01224HS01418HSOI622H501815HS02000HS02176HS02355HS02513HS02677HS00289HS00567H500758HS01012HS01228HS01420H501624HSOI819HS02001H502191HS02356HS02516HS02680H500294H500573H500759
HSOSJIO1,216 of 1,216 codes
HSOI232HSOI424H501625H501823H502002H502193H502359H502518H502681HS00303H500574H500762HSOI020HSOI233HSOI432HSOI631H501824HS02006HS02196H502360H502521H502682H500309H500576H500764HSOI034HSOI235HSOI434H501633H501832HS02012HS02198H502362H502524HS02683H500317H500577H500768H501038H501236H501435H501639H501837H502013H502200H502363H502529HS02684H500321H500579H500775H501040H501240HS01437H501640H501838H502015H502201HS02364H502531
HSOSOOO HSOSIOSHSOS446H504156HS04255HS04349HS0444SHS04574H504677HS04789H504886HS04997HSOSI02HSOS204HSOS317HSOS447HS04157HS04256HS043SOHS04446HS04577HS04678HS04791HS04889HS04998HSOS103HSOS205HS05319HSOS448H504158HS04257HS04353HS04448HS04578HS04679HS04792HS04890
HSOSOOIHSOS207HSOS320HSOS4SOHS04159HS04258HS04356HS04449HS04579HS04680HS04794HS04892
HSOSOOJHSOS106HSOS208HSOS321HSOS4SlH504161HS04261HS04357HS044SOHS04580HS04681HS0479SHS04894HSOS002HSOS121HSOS209HSOS326HSOS453HS04166HS04263HS043S8HS044SlHS04581HS04682HS04798HS0489S
HSOSOOSH505122HSOS211HSOS329HSOS456HS04168HS04264HS04360HS04452HS04586H504687HS04800HS04898HSOS004HSOS123HSOS212HS05330HS05457HS04169HS0426SHS04361HS04453HS04587HS04689HS04801HS04899
HSOSJJSHSOS12SHSOS214HSOS331HSOS458H504170HS04266HS04362HS04454HS04594HS04690HS04802HS04900HSOS006HSOS126HSOS216
HSOSOIO HSOSIJOHSOS460HS04171HS04268HS04364HS044SSHS04597HS04692H504803HS04905HSOS008HSOSI27HSOS217HSOS336HSOS461HS04172HS04269HS04367HS04460HS04601HS04694HS04804HS04906HSOS009HSOSI28HSOS218HSOS338H505463HS04173HS04270HS04368HS04461HS04603HS0469SHS04806HS04907
HSOSOIIHSOS220HSOS339HSOS466HS04174HS04271HS04369HS04462HS04604H504697HS04808HS04908
HSOSOISHSOSI32HSOS229HS05343HSOS467H50417SHS04272HS04370HS04464HS04607H504702H504809HS04911HSOSOI2HSOSI33HSOS232HSOS344HSOS468H504176HS04273HS04371HS04470HS04608HS04703HS04810HS04912HSOSOI3HSOS138HSOS233HSOS34SHSOS472HS04177HS04274HS04372H504472H504610HS0470SHS04811HS04913HS05014HSOS140HSOS234HSOS346HSOS473HS04178HS04275HS04373HS04473HS04611HS04706HS04812HS04914
'HS04278HSOSI41H505236HSOS347HSOS477HS04179HS04276HS04374HS04475HS04612HS04707HS0481SHS04916HSOS017HSOS142HSOS238HSOS348HSOS496HS04180
HSOSSOOHS04375HS04477HS04614H504708HS04816H504917H505018H505144HSOS239H505349HS05498HS04181HS04282HS04377HS04480H504616HS04711HS04817H504919HSOS019H50514SH505240H505350
HSOSSOJHS04182HS04283HS04378HS04481HS04617H504713HS04823HS04920HSOS020H50Sl46HSOS241H505351
HSOSJSJ HSOSSOSHS04183H504284H504380HS04482H504618HS04717HS04824HS04921HSOS021H50Sl47HSOS242HSOS352HSOSS04HS04184HS0428SHS04383HS0448SHS04620HS04724HS04829HS04924HSOS022HSOSI48HSOS243
HSOSISO HSOS244 HSOSJSSHS0418SHS04287HS04387HS04486HS04621HS04726HS04830HS04925HSOS023
HSOSISIHSOSS06HS04186HS04289HS04388H504488HS04622HS04727HS04831HS04926HSOS02S
HSOSSISHSOS24SHS05357H505507H504187H504292HS04390HS04490HS04623H504728HS04832HS04927H505026H505153H505247HSOS361HS05508HS04192H504293H504391H504494HS04624H504729HS04833H504928H505027HSOSIS6H505248HSOS36SH505513H504194HS04297H504392H504498H504628H504730HS04834H504930H505028H505157H505249HS05372HSOS514HS04197H504298H504393H504499H504630HS04733H504835H504934HSOS031HSOS158H505250H505373
HSOSOJSH504198H504300HS04394HS04500H504631H504734H504837H504936HSOS033H505161HS05251H505379H505516H504199HS04301HS04396H504502H504632H50473SH504838HS04937
HSOSOSS77 of 77 codes
HSOS162H505252H505383H505517H504200H504304H504397H504503H504635HS04737H504839H504938H505043H505164H505253H505384H505518H504201HS04305H504399H504504H504636HS04738H504840H504939H505044H505165H505254H505385HS05519HS04207HS04308HS04400HS04SOSHS04637HS04739HS04841HS04940HSOS047HSOSI66HSOS2SSHSOS386HSOSS27HS04208HS04309HS04401HS04516HS04638HS04740HS04842HS04941HSOSOS2HSOS167HS05261HSOS387H505528HS04210HS04310HS04402HS04517
HSOSSSS169 of 169 codes
H505169HSOS263HSOS390HSOSS38HS04212H504313H504405H504520H504643HS04748HS04848HS04946HSOSOS6HSOSI70HS05265H505393HSOS540HS04213HS04316HS04406H504522HS04644HS04749HS04850HS04949HS05059H505172HSOS266HSOS397H505541HSOSS42HSOS706HSOS896HSOS607HS0575SHSOS638HSOS810HSOSS80HSOS738HSOS966HSOS626HS05780HSOS663HSOSS43HSOS707HS05897H505608HSOS758HS05639HSOS815HSOSS88HS05739HS06000HSOS627HSOS781H505664HS05544HSOS708HSOS90SHSOS609
HS05684HSOS689HSOS690HS05694HS05696HSOS701HSOS703HSOS704HS05874H505884H50588SHSOS887HSOS889HSOS891HSOS894HSOS89S
- CODES
- Amount recalled
- 2508 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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