Auris Health recalls Monarch Platform devices with software version 2.2.4 due to potential virtual bronchoscope image flipping. Affected units may require software update to prevent display errors.
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Auris Health is recalling Monarch Platform medical devices with software version 2.2.4 because software issues could flip the virtual bronchoscope view. This might cause misdiagnosis during procedures if the image appears incorrectly.
The software issue could cause the virtual bronchoscope view to flip, potentially leading to misdiagnosis. This might happen during medical procedures where accurate visualization is critical. However, the risk is not described as causing serious injury in normal use.
Healthcare providers using the Monarch Platform for bronchoscopy procedures are most at risk. Patients undergoing these procedures may be affected if the image display is incorrect.
Check for the Monarch Platform with software version 2.2.4. The device model includes REF MON-000005-01 and operates at 100-240V with 50/60Hz frequency.
Verify the software version on your Monarch Platform device to confirm if it is 2.2.4.
The recall record does not mention any risk of serious injury; it only states potential image flipping.
The recall record does not specify a remedy; the software version may need to be updated by the manufacturer.
Check the software version to see if it is 2.2.4. If so, contact Auris Health for guidance on updating the software.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0448-2024 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-0448-2024 from Auris Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
