Events

Recall of Device Recall Ultrasound Video Gastroscope, Model EG3670URK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pentax of America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77380
  • Event Risk Class
    Class 2
  • Event Number
    Z-3067-2017
  • Event Initiated Date
    2017-05-23
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155880
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
  • Reason
    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.
  • 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.

Device

Device Recall Ultrasound Video Gastroscope, Model EG3670URK
  • Model / Serial
    Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411,  H110497, G110360, G110363, G110364, G110371, G110366, G110368,  G110372, H110434, H110447, G110380, H110455, G110298, H110445,  H110449, H110461, G110292, G110346, G110365, H110494, H110495,  H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467,  H110471, H110412, G110289, G110303, G110294, H110420, G110299,  G110300, H110448, H110452, G110386, G110331, H110451, H110493,  G110313, G110314, H110464, H110496, H110433, G110373, G110375,  G110317, H110431, H110417, G110291, G110302, G110369, G110378,  G110335, G110387, G110390, G110392, G110395, G110311, G110327,  G110332, G110382, G110355, G110357, G110287, G110320, H110435,  H110481, H110485, H110486, G110354, G110316, G110318, G110362,  G110393, H110498, H110456, H110457, H110459, G110337, G110356,  H110421, H110429, G110290, G110352, H110470, H110478, G110383,  G110384, G110361.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    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 the upper gastrointestinal tract from esophagus through duodenum.
  • Manufacturer
    Pentax of America Inc

Manufacturer

Pentax of America Inc
  • Manufacturer Address
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA