Video Cytoscopes
Reported: June 21, 2017 Initiated: January 11, 2011 #Z-2325-2017
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.
Details
- Recalling Firm
- Pentax of America Inc
- Units Affected
- 1,349 - (Total - US) and 352 (Total - OUS)
- Distribution
- US Nationwide and Internationally
- Location
- Montvale, NJ
Frequently Asked Questions
What product was recalled? ▼
Video Cytoscopes. Recalled by Pentax of America Inc. Units affected: 1,349 - (Total - US) and 352 (Total - OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2325-2017.
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