Recall Z-2116-2014 ยท FDS Gastroscope And Accessories, Flexible/Rigid
Pentax Medical Company
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.
| Date | Jul 24, 2014 (initiated Jun 12, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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 : paul.silva@pentaxmedical.com |
| Quantity | 531 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |