Medical device recalls Moderate risk

Pentax of America Inc recalls Video Cytoscopes

Recall date
January 11, 2011
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2325-2017
FDA classification
Class II
Brand / firm
Pentax of America Inc
Sold / distributed
US Nationwide and Internationally

Why it was recalled

This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

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

What was recalled

Video Cytoscopes

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