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Terminated

Video Naso pharyngo Laryngoscopes

FDA Recall Z-2326-2017 · Posted None

Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeEOQ
Date Initiated2011-01-11
Date Terminated2018-03-13
Product Quantity1,349 - (Total - US) and 352 (Total - OUS)

Reason for Recall

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.

Firm Action

Customers were visited by members of Pentax America, Inc. field service team. The field service technicians inspected the affected devices, and documented the inspections using the Inspection Record Form (QS-397).

Root Cause

Device Design

Distribution Pattern

US Nationwide and Internationally

Official Source

View FDA Recall →

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

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