Auris Health recalls Monarch Platform devices with software version 2.2.4 due to potential virtual bronchoscope image flipping. Affected units may need 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 cause the virtual bronchoscope view to flip. This might lead to incorrect medical imaging during procedures.
The software issue could cause the virtual bronchoscope view to flip, potentially leading to incorrect visualization of the airway during procedures. This might result in misdiagnosis or improper treatment decisions.
Medical professionals using the Monarch Platform for bronchoscopy procedures are most likely affected. Patients undergoing these procedures may also be impacted if the image flipping occurs.
Check for the Monarch Platform with software version 2.2.4. The device model is REF MON-000005-01R, rated for 100-240V and 50/60Hz power.
Verify the software version on your Monarch Platform device. If it is 2.2.4, it is affected.
The recall is for potential image flipping in the virtual bronchoscope view, which could lead to incorrect medical imaging. However, the hazard is not described as causing serious injury, so it is considered low risk.
The official recall does not specify a fix. Affected users should check for software updates or contact Auris Health for further instructions.
If your Monarch Platform has software version 2.2.4, you should check for updates or contact Auris Health directly for assistance.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0449-2024 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-0449-2024 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.
