Events

Recall of Smartair ST;Smartair Plus;Legendair Double Branch;Legendair Simple Branch

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Tyco Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2007-09-20
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-ventilateurs-airox-tyco-healthcare
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    On 19 September 2007, the company TYCO HEALTHCARE France withdrew from the market the batches of the references specified in the annex (20/09/2007) (11 KB) of the medical device called "AIROX Supportair fans, Smartair ST, Smartair Plus, Legendair Double Branch , Legendair Simple Branch "manufactured by AIROX, following several reports reporting a shutdown of the fan. The company TYCO HEALTHCARE has directly notified the recipients of the incriminated lots with the message attached (20/09/2007) (21 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The competent European authorities concerned shall be informed of this measure by the distributor.

Device

Smartair ST;Smartair Plus;Legendair Double Branch;Legendair Simple Branch
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Tyco Healthcare

Manufacturer

Tyco Healthcare
  • Source
    LAANSM