Recall Z-3289-2018— Olympus Corporation of the Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2018-08-08, terminated 2022-05-17. It names 2 FDA 510(k) clearances: K023984, K963033. Product: Bronchovideoscope BF-240. Reason: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port..
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-08
- Terminated
- 2022-05-17
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
2 on FDA's record- K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
- K963033 — BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Bronchovideoscope BF-240
Reason for recall
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
Data sourced from openFDA. This site is unofficial and independent of the FDA.