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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
2026-01-21Z-1383-2026Class IIOpen, ClassifiedDevice for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.Distribution: Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada.173clearance family
2023-10-18Z-0448-2024Class IIOpen, ClassifiedTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.Distribution: US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.110 units In totalclearance family
2023-10-18Z-0449-2024Class IIOpen, ClassifiedTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.Distribution: US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.110 units In totalclearance family
2023-10-18Z-0450-2024Class IIOpen, ClassifiedTheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view.Distribution: US Distribution: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, SC, SD, TN, TX, WI & WV.110 units In totalclearance family
Regulatory clearances
  • 510(k)K193534Substantially equivalent (SESE) · 2020-04-15clearance family

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
2020-02-07NAINo action indicatedAuris Health Inc.0
2020-02-06NAINo action indicatedAURIS HEALTH INC0
2020-02-06NAINo action indicatedAURIS HEALTH INC0
2017-07-11NAINo action indicatedAuris Health Inc.0
2017-02-13NAINo action indicatedAuris Health Inc.0
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