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Olympus Corporation of the Americas: EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Medical DevicesSource: FDA (device) · Date: 2025-10-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Reason / hazard
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 therapy equipment.
Classification
Class I
Status
Ongoing
Distribution / sold at
US Nationwide Distribution.
Recall initiated
2025-09-11
Code info
Model No. BF-XT190; UDI: 4953170402470; All Serial No.
Product quantity
361 units US; 258 units OUS
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
97441
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