Reported Feb 25, 2026 · Ongoing
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB,…
Auris Health, Inc.
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: Auris Health, Inc · 5490 Great America Pkwy · Santa Clara, CA · 95054-3644
Is this the product you have?
- MONARCH Platform, Bronchoscopy
- Catalog Numbers
MON-000005-01MON-000005-01RMON-000006MON-000006-RFBMON-000008 with software
- Lot codes and dates
- Software versions
2.2.22.2.32.2.42.2.5and 4.1.1
- UDI-DI
1081006881080310810068810988
- Serial Numbers
173 of 173 codes
110024120088120057120046120058120015120160120068120081120056110028120128120017120089120075110016120031120169120113120168120055120014120060120174120195120026110038120124120194110027110035120123120091120007110022120006120152120004120120120041120106110034120126120082120151120051120020120153120193120170120108120037120074120199120130120095110026120096120009120111
- Software versions
- Amount recalled
- 173
Where it was sold
Why it was recalled
Device 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.
This product could cause temporary or reversible health problems — stop using it.
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