Events

Alerte De Sécurité sur Indoplas Infrared Ear Thermometer

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 manufacturer #17352.

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
    2018-120
  • 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/499426-fda-advisory-no-2018-120
  • 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. 2018-120 public health warning against the purchase and use of the unregistered medical device product (indoplas infrared ear thermometer) the food and drug administration (fda) advises the general public and all healthcare professionals against the purchase and use of the unregistered medical device indoplas infrared ear thermometer: fda post-marketing surveillance (pms) activities have verified that the abovementioned medical device has not gone through the registration process of the agency and has not been issued with proper authorization in the form of certificate of product registration (cpr). pursuant to republic act 9711, otherwise known as the “food and drug administration act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from fda is prohibited. accordingly, since this unregistered medical device has not gone through evaluation and testing process of the fda, the agency cannot guarantee its quality and safety. the consumption of such violative product may pose potential health hazards to the consuming public. in light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against medical device that might not be duly registered with fda. always check if a medical device has been registered with the fda before purchasing it by making use of the embedded search feature of the fda website accessible at www.Fda.Gov.Ph. all concerned establishments and/or entities are warned not to distribute the above-identified violative medical device until it has already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued. for more information and inquiries, please e-mail us at this 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. 2018-120.Pdf.

Device

Indoplas Infrared Ear Thermometer

Manufacturer

manufacturer #17352