Class I - Dangerous
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
AURIS HEALTH
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Class I - Dangerous
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Class I - Dangerous
Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Class I - Dangerous
Reports of aspirating biopsy needle breakage