Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Bronchovideoscope BF-160

Recall date
August 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3283-2018
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
The products were distributed US nationwide and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bronchovideoscope BF-160

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