Auris Health recalled 173 bronchoscopy devices due to a software malfunction. This issue could lead to improper robotic arm positioning, risking patient safety. The recall affects devices distributed nationwide and in Canada, with the announcement made on January 21, 2026.
Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Auris Health, Inc or your healthcare provider for instructions
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The MONARCH Platform bronchoscopy device assists healthcare professionals with bronchoscopic visualization and patient airway access. It is commonly used in medical procedures to help diagnose and treat airway issues.
The device's software issue can cause the robotic arm to reposition unexpectedly, which may lead to contact with the patient or endotracheal tube during procedures.
This recall is not part of a broader industry pattern.
This recall can significantly affect medical practices using the device, delaying procedures and requiring immediate alternatives for patient care.
Catalog numbers and software versions can typically be found on the device's identification plate or user manual.
Expect refund processing to take 4-6 weeks once the manufacturer receives your request.
Keep all correspondence related to the recall, including emails, receipts, and photos of the device.
The recalled MONARCH Platform bronchoscopy devices include catalog numbers MON-000005-01, MON-000005-01R, MON-000006, MON-000006-RFB, and MON-000008. These devices were sold worldwide, including states like MN, FL, NJ, NY, and others.
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