The Recall Desk

FDA (Devices) recall action 77380

Pentax of America Inc recalled 2 products on 2017-08-30

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-08-30
Critical
0
Units
234

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2017-08-30

    Pentax Ultrasound Video Gastroscope Recall Due to Instruction Error

    Pentax of America Inc is recalling 116 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-08-30

    Pentax Ultrasound Video Gastroscope Recalled for Incorrect Disinfection Instructions

    Pentax of America Inc. is recalling 118 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    Product
    Ultrasound Video Gastroscope, Model EG-3670URK, 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
    Category
    Distribution
    0 states