Video Cytoscopes
- Company
- Pentax Of America Inc
- Recall Initiated
- January 11, 2011
- Terminated
- March 13, 2018
- Recall Number
- Z-2325-2017
- Quantity
- 1,349 - (Total - US) and 352 (Total - OUS)
- Firm Location
- Montvale, NJ
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.
Distribution
US Nationwide and Internationally
Lot / Code Info
Model #'s:ECY-1570 and ECY-1570K
Root Cause
Device Design
Action Taken
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).
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