Reported Aug 30, 2017 · Terminated
Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound…
Pentax of America Inc
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pentax of America Inc · 3 Paragon Dr · Montvale, NJ · 07645-1782
Is this the product you have?
- 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.
- Lot codes and dates
198 of 198 codes
H110516H110619H110635H110643H110624A110407A110411H110507A110352A110444A110417A110419H110493H110494H110522H110584H110586H110590H110591H110559A110471A110474A110355A110359H110606H110566H110568H110498H110503H110509H110510H110637H110560H110514A110427A110372A110438H110587H110598H110600A110439A110440A110443A110450A110448A110451A110453H110542H110569A110445A110454H110565A110356A110357H110592H110593H110595A110346H110508A110461
- Amount recalled
- US: 116 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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