Recall Z-0686-2024 ยท EOQ Bronchoscope (Flexible Or Rigid)
Shirakawa Olympus Co., Ltd.
Model No. BF-P190, EVIS EXERA III Bronchovideoscope
| Date | Jan 9, 2024 (initiated Dec 4, 2023) |
| Status | Open, Classified |
| Reason | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| Root cause | Under Investigation by firm |
| Action | On December 4, 2023, the firm notified customers of the recall via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the updates to the instructions for use (IFU). Customers were instructed to ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions. Please locate and replace any on-hand copies of the IFU with the updated version. The most current version of the Instructions for Use can be obtained from the Olympus Connect customer web portal at https://www.OlympusConnect.com. New users will need to register. |
| Quantity | 2600 US; 3214 OUS |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 Olympus Medical Systems Corp., Jan 21, 2021 |