Recall Z-0448-2024— AURIS HEALTH INC

Name: FDA recall Z-0448-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-18

Class II · Ongoing

Class II FDA medical device recall by AURIS HEALTH INC, initiated 2023-10-18. It names one FDA 510(k) clearance: K193534. Product: Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w. Reason: Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view..

Recalling firm: AURIS HEALTH INC
Classification: Class II
Status: Ongoing
Initiated: 2023-10-18
Firm location: Redwood City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K193534 — Monarch PlatformAuris Health, Inc.·cleared 2020-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.