Recall Z-2569-2021 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
| Date | Aug 16, 2021 |
| Status | Terminated |
| Reason | The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Root cause | Reprocessing Controls |
| Action | On August __, 2021, the firm distributed Urgent Medical Device Corrective Action letters to customers. The applicable addenda to the reprocessing instructions were attached to the letters. Action steps to be taken by the end user: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information o |
| Quantity | 644 |
| Distribution | Domestic distribution nationwide. Product also distributed globally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd., Oct 16, 2003 |