| 2026-01-21 |
Class II
|
Ongoing |
Z-1383-2026 |
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-00000… |
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Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope lo… |
| 2025-10-18 |
Class II
|
Ongoing |
Z-0543-2026 |
MONARCH Bronchoscope. Model Number: MBR-000211-B |
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Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. |
| 2024-08-02 |
Class II
|
Ongoing |
Z-0052-2025 |
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB |
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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 t… |
| 2024-08-02 |
Class II
|
Ongoing |
Z-0051-2025 |
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, M… |
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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 t… |
| 2023-10-18 |
Class II
|
Ongoing |
Z-0450-2024 |
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w |
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Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. |
| 2023-10-18 |
Class II
|
Ongoing |
Z-0449-2024 |
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w |
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Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. |
| 2023-10-18 |
Class II
|
Ongoing |
Z-0448-2024 |
Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w |
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Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view. |