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.
FDA Recall Z-2116-2014 · Posted 2014-07-24
Recalling FirmPentax Medical Company
Recall StatusTerminated
Product CodeFDS
Date Initiated2014-06-12
Date Terminated2015-11-17
Product Quantity531 units
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.
Firm 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 : [email protected]
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.