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Terminated

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

FDA Recall Z-2497-2021 · Posted None

Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeEOQ
Date Initiated2021-08-17
Date Terminated2024-01-12
Product Quantity27 globally (21 US)

Reason for Recall

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

Firm Action

On August 17, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were informed that Olympus will repair your unit free of charge. An Olympus representative will contact you to make arrangements for return of your affected bronchoscope. If you have further questions about this recall, please contact [email protected] for additional information.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESThe Olympus Optical Co. · 2003-01-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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