Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Recall Z-3068-2017 · Posted None
Advertisement
Recalling FirmPentax of America Inc
Recall StatusTerminated
Product CodeODG
Date Initiated2017-05-23
Date Terminated2020-05-21
Product QuantityUS: 116 units
Reason for Recall
Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.
Firm Action
Recall Notifications were sent to 104 consignees via USPS Certified Mail on 5/23/2017. Included with the Field Safety letter was the customer response form, and the addendum to IFU Z845. These were also posted on Pentax of America web page until the recall is closed.
Root Cause
Error in labeling
Distribution Pattern
Nationwide
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