Reported Apr 30, 2014 · Terminated
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The…
Varian Medical Systems, Inc.
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. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors
- Product UsageThe On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks
- Lot codes and dates
- Model H08Code
- numbersHOSOOOS
H080002H080065H080126H080187H080251H080314H080378H080441H080503H080607H080672H080749H080944H080003H080066H080127H080188H080252H080315H080379H080442H080504H080608H080673H080753H080947H080004H080068H080128H080189H080254H080316H080380H080443H080506H080609H080674H080754H080948
HOSOSlOH080069H080129H080190H0802SSH080317H080381H080444H080507H080610H080675H0807SSH080950H080006H080071H080130H080191H080256H080318H080382H080445H080508H080611H080676H080756H080960H080008H080072H080131H080192H080257H080319H080383H080446H080509H080612H080677H080759H080961H080009H080073H080132H080193H080258H080320H080384H080447
HOSOOSO83 of 83 codes
H080613H080678H080760H080962H080010H080074H080133H080194H080259H080321H08038SH080448H080511H080614H080679H080761H080969H080011H080075H080134H080195H080260H080322H080386H080449HOSOS12H080615H080680H080762H080970H080012H080076H080136H080196H080261H080324H080387H080450H080513H080616H080683H080763H080971H080013H080077H080137H080197H080262H080325H080389H080451H080514H080617H080684H080764H080989H080014H080078H080138H080198
HOSOOSlH080141H080200H080266H080328H080393H080454H080517H080620H080687H080772H081001H080018
HOSOOSS453 of 453 codes
H080142H080202H080267H080329H080394H080455H080518H080621H080688H080773H081004H080019H080082H080143H080203H080268H080330H080395H080456H080519H080622H080689H080774H081005H080020H080083H080144H080204H080269H080331H080396H080457H080520H080623H080690H080775H081006H080021H080084H080145H080205H080270H080332H080397H080458H080521H080624H080691H080778H081007H080022H080085H080147H080206H080271H080333H080398H080459H080522H080625
HOSOSSSH080117H080178H080239H080305H080366H080431H080493H080554H080662H080738H080903H081087H080056H080118H080179H080240H080306H080368H080432H080494
HOSOSOO63 of 63 codes
H080663H080739H080904H081088H080057H080119H080180H080243H080307H080369H080433H080495H080557H080664H080740H080913H081095H080059H080120H080181H080244H080308H080371H080435H080497HOBOS58H080665H080741H080924H081096H080060H080121H080182H080245H080309H080373H080436H080498H080601H080666H080742H080929H081100H080061H080122H080183H080246H080310H080374H080437H080499H080602H080667H080745H080930H081105H080062H080123H080184H080247
1,899 of 1,899 codes
H080604H080668H080746H080936H081107H080063H080124H080185H080248H080312H080376H080439H080501H080605H080669H080747H080939H081108H080064H080125H080186H0802SOH080313H080377H080440H080502H080606H080670H080748H080943H081109H081110H082044H082106H082171H082234H082298H082363H082490H082553H082619H082684H082749H082813H081112H08204SH082107H082172H082235H082299H082364H082491H082SSSH082620H082685H082750H082814H08111SH082046H082108
- Amount recalled
- 2622
Why it was recalled
Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
This product could cause temporary or reversible health problems — stop using it.
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