Events

Rappel de Device Recall Blanketrol III Data Export Software

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 Cincinnati Sub-Zero Products 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
    66632
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0443-2014
  • Date de mise en oeuvre de l'événement
    2013-05-15
  • Date de publication de l'événement
    2013-12-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122858
  • 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, thermal regulating - Product Code DWJ
  • Cause
    During a customer inquiry regarding a beta version of the bill data export software, model usb-127, it was discovered that the wrong software version was released to a customer.
  • Action
    Cincinnati Sub-Zero sent a Urgent Medical Device Notification letter dated July 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They instructed their customers to to do the following: 1) Upon receipt of the corrected Blanketrol III Data Export Software disc, immediately collect and destroy all previous Blanketrol III Data Export Software disc from this lot # currently in possession and replace all downloaded Blanketrol III Data Export Software with the correct version provided by CSZ. 2) After the Blanketrol Data Export Software Version 1.00 have been destroyed and downloaded versions replaced with version 1.10, complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by fax to (513) 772-9119 scan and e-mail the information to BIIIExportSoftware@cszinc.com, or mail to: Cincinnati Sub-Zero 12011 Mosteller Road Cincinnati, OH 45241 U.S.A. For further questions please call 1-(800) 989-7373 or (513) 772-8810.

Device

Device Recall Blanketrol III Data Export Software
  • Modèle / numéro de série
    Product/Part #86127, Catalog #USB-127, Lot #00554
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.
  • Description du dispositif
    Blanketrol III Data Export Software Version 1.10 || The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Adresse du fabricant
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Société-mère du fabricant (2017)
    Gentherm, Inc.
  • Source
    USFDA