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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93320

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 18, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
AURIS HEALTH INC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-0448-2024
Recall number
Z-0448-2024
Initiated
October 18, 2023
Classification
Class II
Status
Ongoing
Recalling firm
AURIS HEALTH INC
Quantity
110 units In total

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Software Version 2.2.4

Distribution pattern

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.

device · product 2 of 3

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

Z-0449-2024
Recall number
Z-0449-2024
Initiated
October 18, 2023
Classification
Class II
Status
Ongoing
Recalling firm
AURIS HEALTH INC
Quantity
110 units In total

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Software version 2.2.4

Distribution pattern

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.

device · product 3 of 3

Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

Z-0450-2024
Recall number
Z-0450-2024
Initiated
October 18, 2023
Classification
Class II
Status
Ongoing
Recalling firm
AURIS HEALTH INC
Quantity
110 units In total

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software issues may result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Software version 2.2.4

Distribution pattern

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.