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
  • numbers
    • H080002
    • H080065
    • H080126
    • H080187
    • H080251
    • H080314
    • H080378
    • H080441
    • H080503
    • H080607
    • H080672
    • H080749
    • H080944
    • H080003
    • H080066
    • H080127
    • H080188
    • H080252
    • H080315
    • H080379
    • H080442
    • H080504
    • H080608
    • H080673
    • H080753
    • H080947
    • H080004
    • H080068
    • H080128
    • H080189
    • H080254
    • H080316
    • H080380
    • H080443
    • H080506
    • H080609
    • H080674
    • H080754
    • H080948
    HOSOOOS
    • H080069
    • H080129
    • H080190
    • H0802SS
    • H080317
    • H080381
    • H080444
    • H080507
    • H080610
    • H080675
    • H0807SS
    • H080950
    • H080006
    • H080071
    • H080130
    • H080191
    • H080256
    • H080318
    • H080382
    • H080445
    • H080508
    • H080611
    • H080676
    • H080756
    • H080960
    • H080008
    • H080072
    • H080131
    • H080192
    • H080257
    • H080319
    • H080383
    • H080446
    • H080509
    • H080612
    • H080677
    • H080759
    • H080961
    • H080009
    • H080073
    • H080132
    • H080193
    • H080258
    • H080320
    • H080384
    • H080447
    HOSOSlO

    83 of 83 codes

    • H080613
    • H080678
    • H080760
    • H080962
    • H080010
    • H080074
    • H080133
    • H080194
    • H080259
    • H080321
    • H08038S
    • H080448
    • H080511
    • H080614
    • H080679
    • H080761
    • H080969
    • H080011
    • H080075
    • H080134
    • H080195
    • H080260
    • H080322
    • H080386
    • H080449
    • HOSOS12
    • H080615
    • H080680
    • H080762
    • H080970
    • H080012
    • H080076
    • H080136
    • H080196
    • H080261
    • H080324
    • H080387
    • H080450
    • H080513
    • H080616
    • H080683
    • H080763
    • H080971
    • H080013
    • H080077
    • H080137
    • H080197
    • H080262
    • H080325
    • H080389
    • H080451
    • H080514
    • H080617
    • H080684
    • H080764
    • H080989
    • H080014
    • H080078
    • H080138
    • H080198
    HOSOOSO
    • H080141
    • H080200
    • H080266
    • H080328
    • H080393
    • H080454
    • H080517
    • H080620
    • H080687
    • H080772
    • H081001
    • H080018
    HOSOOSl

    453 of 453 codes

    • H080142
    • H080202
    • H080267
    • H080329
    • H080394
    • H080455
    • H080518
    • H080621
    • H080688
    • H080773
    • H081004
    • H080019
    • H080082
    • H080143
    • H080203
    • H080268
    • H080330
    • H080395
    • H080456
    • H080519
    • H080622
    • H080689
    • H080774
    • H081005
    • H080020
    • H080083
    • H080144
    • H080204
    • H080269
    • H080331
    • H080396
    • H080457
    • H080520
    • H080623
    • H080690
    • H080775
    • H081006
    • H080021
    • H080084
    • H080145
    • H080205
    • H080270
    • H080332
    • H080397
    • H080458
    • H080521
    • H080624
    • H080691
    • H080778
    • H081007
    • H080022
    • H080085
    • H080147
    • H080206
    • H080271
    • H080333
    • H080398
    • H080459
    • H080522
    • H080625
    HOSOOSS
    • H080117
    • H080178
    • H080239
    • H080305
    • H080366
    • H080431
    • H080493
    • H080554
    • H080662
    • H080738
    • H080903
    • H081087
    • H080056
    • H080118
    • H080179
    • H080240
    • H080306
    • H080368
    • H080432
    • H080494
    HOSOSSS

    63 of 63 codes

    • H080663
    • H080739
    • H080904
    • H081088
    • H080057
    • H080119
    • H080180
    • H080243
    • H080307
    • H080369
    • H080433
    • H080495
    • H080557
    • H080664
    • H080740
    • H080913
    • H081095
    • H080059
    • H080120
    • H080181
    • H080244
    • H080308
    • H080371
    • H080435
    • H080497
    • HOBOS58
    • H080665
    • H080741
    • H080924
    • H081096
    • H080060
    • H080121
    • H080182
    • H080245
    • H080309
    • H080373
    • H080436
    • H080498
    • H080601
    • H080666
    • H080742
    • H080929
    • H081100
    • H080061
    • H080122
    • H080183
    • H080246
    • H080310
    • H080374
    • H080437
    • H080499
    • H080602
    • H080667
    • H080745
    • H080930
    • H081105
    • H080062
    • H080123
    • H080184
    • H080247
    HOSOSOO

    1,899 of 1,899 codes

    • H080604
    • H080668
    • H080746
    • H080936
    • H081107
    • H080063
    • H080124
    • H080185
    • H080248
    • H080312
    • H080376
    • H080439
    • H080501
    • H080605
    • H080669
    • H080747
    • H080939
    • H081108
    • H080064
    • H080125
    • H080186
    • H0802SO
    • H080313
    • H080377
    • H080440
    • H080502
    • H080606
    • H080670
    • H080748
    • H080943
    • H081109
    • H081110
    • H082044
    • H082106
    • H082171
    • H082234
    • H082298
    • H082363
    • H082490
    • H082553
    • H082619
    • H082684
    • H082749
    • H082813
    • H081112
    • H08204S
    • H082107
    • H082172
    • H082235
    • H082299
    • H082364
    • H082491
    • H082SSS
    • H082620
    • H082685
    • H082750
    • H082814
    • H08111S
    • H082046
    • H082108
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.

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 1, 2015 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.