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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2019-08-12Z-1899-2020Class IITerminatedAfter a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.Distribution: Worldwide distribution - US Nationwide distribution including in the states of TN, FL, IN, PA, NV, WA, DC, CA, AL, IL, MD, VA, TX, MN, AR, GA, OR, MS, MO, NY, SC, DE, AZ, NH, MI, NC, OH, PA and OK. The country of Canada.151 unitscode info di
Regulatory clearances

    Predicate lineage

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2023-09-20NAINo action indicatedVarian Medical Systems, Inc.0
    2023-09-20NAINo action indicatedVarian Medical Systems, Inc.0
    2022-09-07NAINo action indicatedVarian Medical Systems, Inc.0
    2017-09-01NAINo action indicatedVarian Medical Systems, Inc.0
    2017-07-20VAIVoluntary action indicatedVARIAN MEDICAL SYSTEMS HAAN GMBH2
    2017-01-12VAIVoluntary action indicatedVarian Medical Systems Imaging Laboratory GmbH1
    2016-12-15NAINo action indicatedVarian Medical Systems, Inc.0
    2016-12-15NAINo action indicatedVarian Medical Systems, Inc.0
    2016-08-31NAINo action indicatedVarian Medical Systems Inc0
    2016-08-10NAINo action indicatedVarian Medical Systems, Inc.0
    2016-08-10NAINo action indicatedVarian Medical Systems, Inc.0
    2016-01-15NAINo action indicatedVarian Medical Systems, Inc.0
    2016-01-15NAINo action indicatedVarian Medical Systems, Inc.0
    2015-07-10NAINo action indicatedVarian Medical Systems, Inc.0
    2015-07-10NAINo action indicatedVarian Medical Systems, Inc.0
    2015-05-20VAIVoluntary action indicatedVarian Medical Systems, Inc.2
    2015-05-20VAIVoluntary action indicatedVarian Medical Systems, Inc.2
    2014-06-06NAINo action indicatedVarian Medical Systems, Inc.0
    2014-06-06NAINo action indicatedVarian Medical Systems, Inc.0
    2014-06-02NAINo action indicatedVarian Medical Systems Inc0
    2010-05-17WLWarning LetterVarian Medical Systems, Inc.—
    2010-05-17WLWarning LetterVarian Medical Systems, Inc.—
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