Recall Z-0084-2014— Pentax Medical Company
Class I · Terminated
Class I FDA medical device recall by Pentax Medical Company, initiated 2013-09-16, terminated 2014-07-09. It names one FDA 510(k) clearance: K850020. Product: PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.. Reason: PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user..
- Recalling firm
- Pentax Medical Company
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-09-16
- Terminated
- 2014-07-09
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
Reason for recall
PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.