AURIS HEALTH INC
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for AURIS HEALTH INC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-16FDA-DeviceClass IIMonarch Platform (Urology), REF: MON-000007, MON-000007-RFB
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.
- 2024-10-16FDA-DeviceClass IIMonarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
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.
- 2023-12-13FDA-DeviceClass IIMonarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- 2023-12-13FDA-DeviceClass IIMonarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
- 2023-12-13FDA-DeviceClass IIMonarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
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