Reported Dec 26, 2012 · Terminated

Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application,…

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 ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application
  • Model NumberHIT
  • Affected Versions
    • ARIA version 11.0 below 11.0.55
    • Build 11.0.28 and 11.0.34
  • Reference/FSCA IdentifierCP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
Lot codes and dates
  • CODES

    267 of 267 codes

    • HITOO28
    • HIT0963
    • HITl780
    • HIT242S
    • HIT4118RI
    • HIT0632M
    • HITIS87R4
    • HIT2208RS
    • HID088R6
    • HITOO32
    • HIT0983M
    • HITl800
    • HIT2434
    • HIT4263
    • HlT0632Rl
    • HlTlS89M
    • HIT2212
    • HIT3097
    • HITOO49M
    • HIT0983RI
    • HITI8S4
    • HIT244I
    • HIT438I
    • HIT0632R2
    • HITlS89Rl
    • HlT2237M
    • HIT316S
    • HITOl16M
    • HIT0983R2
    • HITl874
    • HIT2477M
    • HIT4439RI
    • HIT0668
    • HITIS89R2
    • HlT2237RI
    • HIT3206
    • HITOI16RI
    • HIT0998
    • HITl898
    • HIT2477RI
    • HIT4SSS
    • HIT0691M
    • HITIS89R3
    • HIT2267M
    • HIT3267
    • HIT0134
    • HITI036
    • HITl9S8
    • HlT2477R2
    • HIT4S92
    • HIT0691RI
    • HlTlS89R4
    • HlT2267RI
    • HIT3268
    • HITOISS
    • HITl119M
    • HITl968
    • HIT2477R3
    • HIT4627
    • HIT0691R2
Amount recalled
264 units

Why it was recalled

Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.

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 Mar 3, 2014 · Data as of Sep 19, 4:52 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.