Events

Rappel de Device Recall BladderScan BVM 9500

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 Verathon, 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
    56411
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0005-2011
  • Date de mise en oeuvre de l'événement
    2010-08-23
  • Date de publication de l'événement
    2010-10-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93550
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Cause
    The bladderscan bvm 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.
  • Action
    Verathon sent an URGENT Medical Device Recall Notification letter dated August 12, 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Verathon provided an addendum to the User Manual with instructions on how to reset the instrument. Customers were advised to: " Add the enclosed addendum to their current Users Manual. " Update the application software of the device to v2.7.0 or higher. If the customers had questions or needed support for the software update process, they were to contact Verathon Medical Customer Care at (425) 867-1348 or (800) 331-2313 or cservice@verathon.com.

Device

Device Recall BladderScan BVM 9500
  • Modèle / numéro de série
    Serial numbers:   B5001000, B5001003, B5001004, B5001007, B5001011, B5001016, B5001017, B5001018, B5001020, B5001021, B5001022, B5001023, B5001024, B5001025, B5001026, B5001027, B5001032, B5001062, B5001069, B5001070, B5001074, B5001075, B5001076, B5001077, B5001078, B5001079, B5001080, B5001081, B5001088, B5001090, B5001091, B5001092, B5001093, B5001095, B5001098, B5001099, B5001101, B5001102, B5001103, B5001104, B5001105, B5001106, B5001107, B5001108, B5001109, B5001110, B5001111, B5001113, B5001114, B5001115, B5001116, B5001117, B5001118, B5001119, B5001120, B5001121, B5001122, B5001123, B5001124, B5001125, B5001126, B5001127, B5001128, B5001129, B5001132, B5001138, B5001139, B5001140, B5001141, B5001142, B5001143, B5001144, B5001147, B5001148, B5001149, B5001150, B5001152, B5001156, B5001157, B5001158, B5001159, B5001160, B5001162, B5001164, B5001166, B5001170, B5001171, B5001172, B5001173, B5001174, B5001175, B5001176, B5001177, B5001179, B5001180, B5001181, B5001182, B5001184, B5001186, B5001187, B5001188, B5001189, B5001190, B5001191, B5001192, B5001194, B5001195, B5001197, B5001198, B5001199, B5001200, B5001201, B5001202, B5001203, B5001204, B5001206, B5001208, B5001209, B5001210, B5001211, B5001212, B5001215, B5001217, B5001218, B5001219, B5001220, B5001221, B5001222, B5001223, B5001224, B5001225, B5001226, B5001228, B5001230, B5001231, B5001233, B5001234, B5001235, B5001236, B5001237, B5001238, B5001239, B5001240, B5001241, B5001245, B5001246, B5001247, B5001249, B5001250, B5001251, B5001252, B5001253, B5001254, B5001256, B5001264, B5001265, B5001266, B5001267, B5001268, B5001269, B5001271, B5001273, B5001274, B5001275, B5001276, B5001277, B5001278, B5001279, B5001280, B5001282, B5001283, B5001285, B5001286, B5001288, B5001289, B5001290, B5001291, B5001292, B5001293, B5001294, B5001295, B5001296, B5001297, B5001298, B5001299, B5001300, B5001302, B5001309, B5001310, B5001313, B5001314, B5001315, B5001316, B5001317, B5001318, B5001319, B5001320, B5001321, B5001322, B5001323, B5001327, B5001328, B5001329, B5001330, B5001331, B5001332, B5001333, B5001334, B5001335, B5001336, B5001338, B5001339, B5001340, B5001341, B5001342, B5001343, B5001344, B5001345, B5001346, B5001347, B5001348, B5001349, B5001350, B5001351, B5001352, B5001353, B5001354, B5001355, B5001356, B5001357, B5001358, B5001359, B5001360, B5001363, B5001364, B5001365, B5001366, B5001367, B5001368, B5001369, B5001370, B5001371, B5001372, B5001373, B5001374, B5001375, B5001376, B5001377, B5001378, B5001380, B5001383, B5001384, B5001385, B5001386, B5001387, B5001388, B5001390, B5001391, B5001392, and B5001393.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Canada, China, Colombia, European Union, United Kingdom, Saudi Arabia, and Singapore.
  • Description du dispositif
    BladderScan BVM 9500 || The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
  • Manufacturer
    Verathon, Inc.

Manufacturer

Verathon, Inc.
  • Adresse du fabricant
    Verathon, Inc., 20001 N Creek Pkwy, Bothell WA 98011-8218
  • Société-mère du fabricant (2017)
    Roper Technologies Inc
  • Source
    USFDA