Events

Alerte De Sécurité sur IF Electrostatic Therapy Device

Selon Food and Drug Administration Philippines, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Philippines qui a été fabriqué par N/A.

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
  • Numéro de l'événement
    2018-259
  • Pays de l'événement
    Philippines
  • Source de l'événement
    FDAP
  • URL de la source de l'événement
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/525482-fda-advisory-no-2018-259
  • Notes / Alertes
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 recall data from the U.S. and Philippines.
  • Notes supplémentaires dans les données
  • Cause
    Fda advisory no. 2018-259 public health warning against the unapproved and misleading advertisements and promotion of if electrostatic therapy device the food and drug administration (fda) warns the public against the unapproved, false and misleading advertisements and promotion of if electrostatic therapy device monitored from flyer collected from ok dok  at 43 annapolis tower greenhills  san juan. the public is hereby warned that the aforementioned claims were not duly approved by the fda. any health device products should not bear any misleading, deceptive and false claims in their labels and/or any promotional materials that will provide erroneous impression on product’s character and identity. hence, false and misleading advertisement of health devices may harm and cause potential risk to the consumers. on the other hand, the false, deceptive and misleading advertisement of these health devices, constitutes violation of title iii, chapter i of the republic act no. 7394, otherwise known as the consumer act of the philippines of 1992.  for more information and inquiries, please e-mail us at cdrrhr_prsddthis email address is being protected from spambots. you need javascript enabled to view it. . or call us at the center for device regulation, radiation health and research (cdrrhr) hotline (02) 857-1900 local 8301.   attachments: fda advisory no. 2018-259.Pdf.

Device

IF Electrostatic Therapy Device
  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP