Recall Z-2324-2017 ยท EOQ Bronchoscope (Flexible Or Rigid)
Pentax of America Inc
Video Bronchoscope
| Date | Jan 11, 2011 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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). |
| Quantity | 1,349 - (Total - US) and 352 (Total - OUS) |
| Distribution | US Nationwide and Internationally |
| FDA record | Open on fda.gov |