Recall Z-2494-2023 ยท PSV Ultrasound Bronchoscope
Olympus Corporation of the Americas
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
| Date | Aug 31, 2023 (initiated Jul 27, 2023) |
| Status | Open, Classified |
| Reason | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. |
| Root cause | Labeling Change Control |
| Action | Consignees were mailed an Urgent Medical Device Correction notification dated 7/27/2023 via UPS. The notification asks that consignees inspect their inventory for recalled devices and check clinical areas to see if any remain in use. Consignees are to ensure that all personnel, including clinical staff, are completely knowledgeable of this recall notification and addendum, which instructs users to slide the endotracheal tube along the entire length of the tracheal intubation scope insertion section to confirm compatibility before using on a patient. Consignees are asked to complete and return |
| Quantity | 4115 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM Olympus Medical Systems Corporation, Jul 5, 2007 |