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.
Recall
- Recall Number
- Z-2116-2014
- Event Number
- 68586
- Firm
- Pentax Medical Company
- FEI Number
- 1000080301
- Product Code
- FDS
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 12, 2014
- Posted
- July 24, 2014
- Terminated
- November 17, 2015
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782
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.
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.
Pentax Medical sent an Urgent Medical Device Field Safety Corrective Action dated June 12, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. Pentax also posted their notification on their website. For questions regarding this action please feel free to contact Paul Silva, Recall Coordinator at Tel: 800-431-5880 ext 2064 (8:30am 5:00pm Mon-Fri, EST) Fax: 201-799-4063 Email : [email protected]
US Nationwide Distribution
531 units