Reported Feb 27, 2013 · Terminated

Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye…

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 Eclipse Treatment Planning System for Radiotherapy
  • Model NumberH48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye
Lot codes and dates
  • 993 of 993 codes

    • H480044
    • H481353
    • H482733
    • H484585
    • H485948
    • H480045
    • H481354
    • H482734
    • H484634
    • H486024
    • H480105
    • H481433
    • H482765
    • H484673
    • H486032
    • H480106
    • H481436
    • H482827
    • H484677
    • H486093
    • H480159
    • H481437
    • H482858
    • H484680
    • H486094
    • H480160
    • H481451
    • H482859
    • H484745
    • H486095
    • H480247
    • H481452
    • H482860
    • H484746
    • H486114
    • H480301
    • H481453
    • H482888
    • H484747
    • H486140
    • H480373
    • H481454
    • H482889
    • H484753
    • H486209
    • H480374
    • H481460
    • H482897
    • H484830
    • H486291
    • H480378
    • H481461
    • H483087
    • H484842
    • H486369
    • H480379
    • H481462
    • H483204
    • H484856
    • H486385
Amount recalled
1168 units

Where it was sold

  • Nationwide

Why it was recalled

The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 4, 2014 · Data as of Sep 19, 5:27 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.