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Recall Observatory FDA recall evidence

Device product

Video Naso pharyngo Laryngoscopes

Z-2326-2017

January 11, 2011

Class II

Product summary

Firm
Pentax of America Inc
Event
Event 77310
Status
Terminated
Classification
Class II
Quantity
1,349 - (Total - US) and 352 (Total - OUS)
Official record key
device-enforcement:Z-2326-2017

Official wording

Reason: 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.

Code information: Model #: VNL-1570STK

Distribution pattern: US Nationwide and Internationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.