Reported Jan 1, 2014 · Terminated

Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions…

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?

  • Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
Lot codes and dates
  • Model numbers H48, HIT
  • H77Code
  • numbers

    985 of 985 codes

    • H480001
    • H480164
    • H480362
    • H480544
    • H480717
    • H480969
    • H481133
    • H481323
    • H481504
    • H48179S
    • H481969
    • H482027
    • H48208S
    • H480004
    • H48016S
    • H48036S
    • H48054S
    • H48072S
    • H480972
    • H481134
    • H481326
    • H481SOS
    • H481796
    • H481970
    • H482028
    • H482086
    • H480009
    • H480174
    • H480373
    • H480546
    • H480727
    • H480974
    • H481138
    • H481327
    • H481506
    • H481804
    • H481971
    • H482029
    • H482087
    • H480010
    • H480175
    • H480374
    • H480547
    • H480760
    • H480975
    • H48114S
    • H481328
    • H481510
    • H48180S
    • H481972
    • H482030
    • H482088
    • H480011
    • H480176
    • H480378
    • H480548
    • H480764
    • H480980
    • H481146
    • H481329
    .

    2,261 of 2,261 codes

    • H484515
    • H484815
    • H484976
    • H482260
    • H482398
    • H482690
    • H482825
    • H483018
    • H483302
    • H483554
    • H483852
    • H484052
    • H484290
    • H484516
    • H484816
    • H484992
    • H482261
    • H482399
    • H482692
    • H482827
    • H483019
    • H483303
    • H483556
    • H483853
    • H484053
    • H484311
    • H484532
    • H484817
    • H484993
    • H482262
    • H482418
    • H482694
    • H482858
    • H483020
    • H483306
    • H483587
    • H483854
    • H484054
    • H484312
    • H484533
    • H484818
    • H484994
    • H482263
    • H482419
    • H482697
    • H482859
    • H483021
    • H483311
    • H483588
    • H483855
    • H484055
    • H484313
    • H484534
    • H484819
    • H484995
    • H482266
    • H482420
    • H482706
    • H482860
    • H483022
    "

    682 of 682 codes

    • H480799
    • H48E043
    • H48E342
    • H48ESS3
    • H48B616
    • H48C040
    • H48C245
    • H48C472
    • H48C660
    • H48C797
    • H480034
    • H480313
    • H480541
    • H480800
    • H48E044
    • H48E343
    • H48ESSS
    • H48B617
    • H48C041
    • H48C246
    • H48C473
    • H48C664
    • H48C798
    • H480039
    • H480314
    • H480547
    • H480803
    • H48E051
    • H48E362
    • H48ESS6
    • H48B630
    • H48C042
    • H48C247
    • H48C474
    • H48C66S
    • H48C799
    • H480040
    • H480315
    • H48DSS4
    • H480804
    • H48EOS2
    • H48E367
    • H48ESS7
    • H48B642
    • H48C04S
    • H48C248
    • H48C47S
    • H48C666
    • H48C800
    • H480051
    • H480316
    • H480SSS
    • H480805
    • H48EOS4
    • H48E368
    • H48E563
    • H48B643
    • H48C046
    • H48C251
    • H48C476
    H48F<l83
    • H48F255
    • H48F351
    • H48FS09
    • H48F646
    • H48F716
    • H48F836
    • H48G015
    • H48G240
    • H48G39S
    • H48GSS3
    • H48E763
    • H48E947
    H48F<l84
    • H48F256
    • H48F352
    • H48F510
    • H48F647
    • H48F718
    • H48F837
    • H48G016
    • H48G243
    • H48G396
    • H48GSS6
    • H48E764
    • H48E948
    H48F<l85
    • H48F257
    • H48F353
    • H48F511
    • H48F648
    • H48F722
    • H48F838
    • H48G017
    • H48G244
    • H48G397
    • H48G559
    • H48E766
    • H48E949
    H48F<l86

    62 of 62 codes

    • H48F258
    • H48F354
    • H48F512
    • H48F649
    • H48F724
    • H48F839
    • H48G020
    • H48G245
    • H48G398
    • H48GS61
    • H48E767
    • H48E950
    • H48F089
    • H48F259
    • H48F355
    • H48F513
    • H48F650
    • H48F727
    • H48F840
    • H48G021
    • H48G246
    • H48G399
    • H48GS66
    • H48E768
    • H48E952
    • H48F120
    • H48F260
    • H48F356
    • H48F514
    • H48F651
    • H48F729
    • H48F841
    • H48G022
    • H48G247
    • H48G400
    • H48G567
    • H48E769
    • H48E954
    • H48F122
    • H48F261
    • H48F357
    • H48FS15
    • H48F652
    • H48F730
    • H48F842
    • H48G039
    • H48G249
    • H48G403
    • H48G568
    • H48E770
    • H48E9SS
    • H48F125
    • H48F262
    • H48F370
    • H48FS16
    • H48F653
    • H48F731
    • H48F851
    • H48G040
    • H48G250
Amount recalled
6701

Why it was recalled

An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.

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 Mar 13, 2015 · Data as of Sep 19, 4:46 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.