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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
2023-08-10Z-2663-2023Class IIOpen, ClassifiedNon-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environmentDistribution: Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.522 unitscode info di
Regulatory clearances

    Predicate lineage

    K060903

    Cited as predicate by: K093995, K110812, K132108, K152473

    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
    2023-02-23VAIVoluntary action indicatedVeran Medical Technologies Inc4
    2021-07-29VAIVoluntary action indicatedVeran Medical Technologies Inc0
    2019-01-31VAIVoluntary action indicatedVeran Medical Technologies Inc0
    2018-02-23VAIVoluntary action indicatedVeran Medical Technologies Inc0
    2015-02-04NAINo action indicatedVeran Medical Technologies Inc0
    2010-08-25NAINo action indicatedVeran Medical Technologies Inc0
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