Recall Z-2325-2017— Pentax of America Inc
Class II · Terminated
Class II FDA medical device recall by Pentax of America Inc, initiated 2011-01-11, terminated 2018-03-13. It names 2 FDA 510(k) clearances: K131946, K131028. Product: Video Cytoscopes. 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..
- Recalling firm
- Pentax of America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-01-11
- Terminated
- 2018-03-13
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K131946 — ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS
- K131028 — PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Video Cytoscopes
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.