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
    2018-237
  • 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/525279-fda-advisory-no-2018-237
  • 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. 2018-237 lifting the advisory of indoplas infrared ear thermometer under fda advisory no. 2018-120 re: “public health warning against the purchase and use of the unregistered medical device product (indoplas infrared ear thermometer)” the food and drug administration (fda) informs the public that the advisory on the medical device product “indoplas infrared ear thermometer” under fda advisory no. 2018-120 dated 02 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. the above-mentioned medical device product is registered with certificate of product registration no. mdr-06882 valid until 29 june 2019 under company indoplas philippines, inc. the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations. 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. . attachments: fda advisory no. 2018-237.Pdf.

Device

Indoplas Infrared Ear Thermometer

Manufacturer

manufacturer #17352