Events

Alerte De Sécurité sur STERRAD NX, Model Plasma Sterilization System Hydrogen Peroxide Sterrad - Registration 10132590628. Product Code 10033, SNs: 0033130118; 0033130544; 0033140005; 0033140026; 0033140012; 0033130288; 0033140050; 0033130424; 0033131009; 0033140011; 0033130276; 0033140021; 0033140040; 0033130441; 0033130250; 0033130277

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1704
  • Date
    2015-10-27
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    The company informs that the STERRAD® NX® Sterilization System may interfere with other electronic equipment used by operators and / or implantable devices used in close proximity to the STERRAD® NX® Sterilization System. Based on our analysis, the risk of interference is low for the active deployment and use devices and other nearby electrical equipment.
  • Cause
    Asp has recently identified that a sterrad® nx® sterilization system may exceed the international standard's radiated emission limit by 20 decibels microvolts per meter (db v / m), which is equivalent to 0.001 volts per meter (v / m) at a distance of 10 meters.
  • Action
    The STERRAD® NX® Sterilization System User Guide (M-99920_07), Chapter 2 - "Safety Information" contains a chapter titled "Guidelines and Declaration - Electromagnetic Emissions", which provides information on emissions testing and guidance on electromagnetic environment, including reporting compliance with CISPR 11, Group 1 and Class A radio frequency (RF) emissions, which is a subset of the IEC-60601-1-2 Medical Electromagnetic Compatibility (EMC) Standards. ASP has identified that the STERRAD® NX® Sterilization System does not meet the limit of the International Standard for Emissions. ASP advises you to continue to take the usual precautions because of the proximity of the STERRAD® NX® Sterilization System with other electromechanical equipment and electronic medical devices at your facility. You should ensure that everyone at your facility who is affected by this notice reads this letter and follows the risk management procedures in the event of use of any affected product. A copy of this communication must be kept with the affected STERRAD® NX® Sterilization System and complete and return the Business Response Form. Further information: Annex II - Alert message.

Device

STERRAD NX, Model Plasma Sterilization System Hydrogen Peroxide Sterrad - Registration 1013259062...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda