Food, drugs, devices › AURIS HEALTH INC
Device recall: Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
AURIS HEALTH INC (Redwood City, CA) initiated this device recall on 18 Oct 2023; FDA lists 3 product records under event 93320, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. AURIS HEALTH INC has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AURIS HEALTH INC, Redwood City, CA.
Reason for recall
"Their 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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0448-2024 | Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w | 110 units In total | Class II | Ongoing | 13 Dec 2023 |
| Z-0449-2024 | Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w | 110 units In total | Class II | Ongoing | 13 Dec 2023 |
| Z-0450-2024 | Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w | 110 units In total | Class II | Ongoing | 13 Dec 2023 |
Context
Other enforcement events for AURIS HEALTH INC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Jan 2026 | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000 | Device | Class II | 1 |
| 18 Oct 2025 | MONARCH Bronchoscope. Model Number: MBR-000211-B | Device | Class II | 1 |
| 2 Aug 2024 | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON- | Device | Class II | 2 |
| 19 Apr 2019 | Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 | Device | Class II | 1 |
All 5 events for AURIS HEALTH INC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.