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 visual errors during procedures.
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 visual errors during medical procedures, but the recall does not mention immediate safety risks.
The software issue could cause the virtual bronchoscope view to flip, potentially leading to incorrect visual interpretation during procedures. This might result in misdiagnosis or delayed treatment if the medical team relies on the flipped image.
Medical professionals using the Monarch Platform for bronchoscopy procedures with software version 2.2.4 are most at risk. Patients using the device may also be affected if the image flip causes misdiagnosis.
Check for the Monarch Platform device with software version 2.2.4. The product is sold as a medical device with specifications 100-240V, 50/60Hz, and 1440w.
Verify your device's software version to see if it is 2.2.4.
The recall states there is a potential for flipped virtual bronchoscope images, but it does not mention immediate safety risks or injuries.
Check for the Monarch Platform device with software version 2.2.4, as specified in the recall.
The recall does not specify a remedy, so you should check for software updates or contact Auris Health for guidance.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0450-2024 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-0450-2024 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.
