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 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.
The software issue may cause the application to restart after patient-side selection. This can lead to the robotic arm moving unexpectedly towards the patient, potentially causing contact with the patient or endotracheal tube.
No specific injuries have been reported, but the malfunction poses a high risk to patient safety due to potential incorrect positioning.
Stop using the bronchoscopy device immediately. Follow the recall instructions from Auris Health or contact your healthcare provider for guidance.
For more information, contact Auris Health, Inc. or visit their website. The recall details can be found at the FDA recall page.
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