Events

Rappel de Device Recall Ultrasound Video Gastroscope, Model EG3670URK

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Pentax of America Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77380
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3067-2017
  • Date de mise en oeuvre de l'événement
    2017-05-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155880
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    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
  • Adresse du fabricant
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    USFDA