FDA recall Z-3068-2017

Product

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.

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-05-23

Report date

2017-08-30

Termination date

2020-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montvale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3068-2017