Recall Z-2116-2014— Pentax Medical Company
Class II · Terminated
Class II FDA medical device recall by Pentax Medical Company, initiated 2014-06-12, terminated 2015-11-17. It names 2 FDA 510(k) clearances: K041396, K041397. Product: EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.. Reason: Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user..
- Recalling firm
- Pentax Medical Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-12
- Terminated
- 2015-11-17
- Firm location
- Montvale, NJ, United States
510(k) clearances named in this recall
2 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
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Reason for recall
Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.