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VIDEO BRONCHOSCOPE
PENTAX OF AMERICA, INC. · Model EB-1970TK · UDI-DI 04961333232192
EOQ
Prescription
1
510(k) clearances
32,212
Adverse events (207 deaths)
160
Recalls
189
Facilities
Description
VIDEO BRONCHOSCOPE 3.2C 6.2TP 600L (REFURBISHED)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-29 | Olympus Corporation of the Americas | Potential for rubber fragment detachment during use. |
| 2026-01-29 | Olympus Corporation of the Americas | Potential for rubber fragment detachment during use. |
| 2026-01-21 | Auris Health, Inc | Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application w |
| 2025-12-04 | Intuitive Surgical, Inc. | Due to probe bags that may have a compromised or incomplete sterile pouch seal. |
| 2025-09-12 | Noah Medical Corporation | Due to Users not having access to the Instructions for Use/User Manual due to it being password protected. |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
| 2025-09-11 | Olympus Corporation of the Americas | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.