Events

Alerte De Sécurité sur Drytec Tc-99m Generator Lot number 5666

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE Healthcare.

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
  • Date
    2009-04-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20080502.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Voluntary recall of device containing non-sterile radioactive material the department of health (dh) received notification from a medical device manufacturing company about its voluntary recall of a batch of radiodiagnostic device which has failed the sterility test. according to the company- uk ge healthcare, the involved batch was known as drytec tc-99m generator lot number 5666. there was a possibility of infection if the non-sterile product was injected into patients. the device is used to prepare radioactive material for injection to patients during radiodiagnostic procedures. information available showed that the affected lot had been used in tuen mun hospital and hong kong sanatorium and hospital. so far, no adverse effect associated with the use of device has been received by dh. the dh has informed the hospital authority, private hospitals, radiodiagnostic laboratories and medical professional associations about the recall and advised them to check for details with the company. dh will continue to monitor the situation and advise the public and health profession accordingly. ends/wednesday, april 23, 2008.

Device

Drytec Tc-99m Generator Lot number 5666
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Voluntary recall of device containing non-sterile radioactive material
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare