Auris Health recalls Monarch Platform endoscopy and bronchoscopy systems with defective power cords that could cause electrical shorts, system shutdowns, or shock if exposed wires contact fluids.
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Auris Health is recalling Monarch Platform endoscopy and bronchoscopy systems due to a potential strain relief defect in power cords that could cause electrical shorts. This might lead to system shutdowns during procedures or electrical shock if exposed wires touch conductive fluids.
The power cords may have a strain relief defect that causes electrical shorts. This can lead to system shutdowns during medical procedures, potentially requiring case conversion. If exposed wires come into contact with conductive fluids or the user touches them, there is a risk of electrical shock.
Healthcare professionals using the Monarch Platform endoscopy or bronchoscopy systems with specific model numbers and serial codes are affected. Operating room staff are most at risk due to potential electrical shock during procedures.
Check for Monarch Platform endoscopy (REF: MON-000005-01, MON-000005-01R) or bronchoscopy (REF: MON-000006) systems with specific power cord model numbers (PN 304-003613-00 or PN 304-003607-00). The serial numbers and reference codes listed in the recall notice indicate affected units.
Inspect the cart and tower power cords for signs of damage or strain relief issues.
Reach out to Auris Health for specific guidance on affected units and potential remedies.
The power cords may have a strain relief defect that could cause electrical shorts, leading to system shutdowns during procedures.
Yes, if exposed wires contact conductive fluids or the user touches them, there is a risk of electrical shock during procedures.
Check the reference codes and serial numbers listed in the recall notice for Monarch Platform endoscopy or bronchoscopy systems with specific power cord model numbers.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0051-2025 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-0051-2025 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.
