CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report

Monarch Platform recalled by Auris Health

Auris Health is recalling Monarch Platform, distributed in 34 states. The recall was initiated on 18 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version 2.2.4

Quantity recalled110 units In total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0449-2024
FDA event ID: 93320
Recalling firm: Auris Health, Redwood City, CA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Oct 2023
FDA classified: 1 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

18 Oct 2023	Recall initiated by company
1 Dec 2023	Classified by FDA	+44 days
13 Dec 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

Where it was distributed

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.

Alaska Alabama Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Illinois Indiana Kentucky Massachusetts Michigan Minnesota Missouri Mississippi Montana North Carolina

Questions about this recall

Why was it recalled?

Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.

Which lots are affected?

Software version 2.2.4

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 93320

This product is part of a recall event; the main page for the event is Monarch Platform recalled by Auris Health.

Reported	Class	Recall	Company	Reason	Where
13 Dec 2023	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states
13 Dec 2023	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states

More recalls from Auris Health

All 8

Reported	Class	Recall	Company	Reason	Where
25 Feb 2026Device	CLASS II	Monarch Platform, Bronchoscopy recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
26 Nov 2025Device	CLASS II	Monarch Bronchoscope recalled by Auris Health	Auris Health	Packaging Defects	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Urology) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
16 Oct 2024Device	CLASS II	Monarch Platform (Endoscopy) recalled by Auris Health	Auris Health	Device Malfunction	Nationwide
13 Dec 2023Device	CLASS II	Monarch Platform recalled by Auris Health	Auris Health	Device Malfunction	34 states

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