Events

Rappel de 3.7 V LiPolymer Battery

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 Invivo Corporation.

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
    50790
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0971-2009
  • Date de mise en oeuvre de l'événement
    2008-08-13
  • Date de publication de l'événement
    2009-02-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77307
  • 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
    Batteries used with Cardiac Monitor - Product Code MWI
  • Cause
    Battery failure: the invivo lithium polymer wireless module battery part number 9065 and the lithium polymer fiber optic module battery part number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. the firms investigation shows that the battery failure does not occur when a module is dropped with a ba.
  • Action
    Urgent Medical Device Recall Notice letters, dated August 2008, and response forms were mailed to each consignee. Distributors were instructed to forward copies of the recall letter and response forms to their customers. The letters identified the affected products, gave the reason for the recall, the hazard involved, how to identify the product, actions to prevent the failure, and procedures to mitigate risk if failure occurs. The letter stated that Invivo would provide replacement batteries but until replacements were provided, customers should handle batteries over an elevated area and to make sure batteries are handled in the absence of paper or other flammable materials. If customers wish to remove the battery from the module in order to conserve battery life, they are to disengage the battery from the module and place the battery on a table or in the battery charger. Do not allow the battery to be disengaged and remain partially inserted in the module as this may cause the battery to slip from the module and fall to the floor.

Device

3.7 V LiPolymer Battery
  • Modèle / numéro de série
    date codes 2808 and lower.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 || These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules.
  • Manufacturer
    Invivo Corporation

Manufacturer

Invivo Corporation
  • Adresse du fabricant
    Invivo Corporation, 12501 Research Pkwy, Orlando FL 32826-3280
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA