EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to the Upper Gastrointestinal Tract, including, but restricted to the organs, tissues, and sub-systems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
FDA Recall Z-1489-2012 · Posted 2012-05-03
Advertisement
Recalling FirmPentax Medical Company
Recall StatusTerminated
Product CodeITX
Date Initiated2012-03-14
Date Terminated2015-07-21
Product Quantity194 units
Reason for Recall
Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during procedure and pre-cleaning procedure.
Firm Action
Pentax sent an "URGENT MEDICAL DEVICE RECALL" letter on March 14, 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. A response form was included for customers to complete and return to the firm. Contact the firm at 800-431-5880 ext. 2064 for questions regarding this notice.
Root Cause
Equipment maintenance
Distribution Pattern
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.
Advertisement