Events

Rappel de Device Recall Aplio XG

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 Toshiba American Med Sys 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
    45811
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0305-2008
  • Date de mise en oeuvre de l'événement
    2007-10-02
  • Date de publication de l'événement
    2008-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66198
  • 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
    Diagnostic Ultrasound System - Product Code IYN
  • Cause
    Panel lock-up: when using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. if the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
  • Action
    Notification letters, Urgent Medical Device Correction, with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.--A short term instruction included "Avoid using the Freeze Key when performing dynamic image acquisitions"

Device

Device Recall Aplio XG
  • Modèle / numéro de série
    SERIAL NUMBERS: 99B0752571, 99B0752572, 99B06Z2073, 99B06Z2102, 99B06Z2107, 99B0722268, 99B0722269, 99B0722270, 99B0722271, 99B0722272, 99B0732349, 99B0732350, 99B0732351, 99B0732352, 99B0732353, 99B0732354, 99B0722208, 99B0722250, 99B0752531, 99B0752532, 99B06Z2072, 99B0752508, 99B0752509, 99B0752510, 99B0752511, 99B0722251, 99B06Z2071, 99B0722206, 99B0722207, 99B0722204, 99B0752524, 99B0752525, 99B0732355, 99B0742413, 99B0742414, 99B0742415, 99B0742416, 99B0742417, 99B0722203, 99B06Z2062, 99B0722201, 99B0712171, 99B0722254, 99B0752507, 99B06Z2064, 99B06Z2104, 99B0712169, 99B0712172, 99B0722202, 99B0752570, 99B0752562, 99B0752563, 99B0752564, 99B0752565, 99B06Z2103, 99B0752523, 99B0752550, 99B06Z2074, 99B0712173, 99B0712174, 99B06Z2059, 99B0752551, 99B0752561, 99B06Z2108, 99B0752549, 99B0722205, 99B0752547, 99B0712168, 99B0722253, 99B06Y2048, 99B06Y2049, 99B06Y2051, 99B06Z2058, 99B06Z2067, 99B06Z2110, 99B06Z2116, 99B06Z2057, 99B06Z2088, 99B06Z2105, 99B06Z2111, 99B06Z2115, 99B0722252, 99B06Z2063, 99B06Z2065, 99B06Z2066, 99B06Z2090, 99B06Z2101, 99B06Z2113, 99B0712170, 99B06Z2060, 99B06Z2068, 99B06Z2070, 99B06Z2106, 99B0752548, 99B06Z2089, 99B06Z2091, 99B06Z2092, 99B06Y2050, 99B06Z2055, 99B06Z2056, 99B06Z2061, 99B06Z2069, 99B06Z2075, 99B06Z2109, 99B06Z2112, and 99B06Z2114
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide: USA including the states of AK, AZ, CA, FL, IA, IL, IN, KS, MI, MN, MO, MT, NE, NV, NY, OH, OR, PR, VA, WI & WV
  • Description du dispositif
    Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
  • Manufacturer
    Toshiba American Med Sys Inc

Manufacturer

Toshiba American Med Sys Inc
  • Adresse du fabricant
    Toshiba American Med Sys Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Source
    USFDA