Events

Rappel Ou Alerte De Sécurité sur Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging systems for intravascular ultrasound and pressure control Volcano s5 and Volcano s5i: device for pulling a single-use catheter Trackback II: 91003

Selon Ministry of Health of the Republic of Belarus, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à Belarus qui a été fabriqué par Volcano Corporation, USA.

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
    Recall / Safety alert
  • Numéro de l'événement
    ИМ-7.99871
  • Date
    2014-01-10
  • Pays de l'événement
    Belarus
  • Source de l'événement
    MHRB
  • URL de la source de l'événement
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alertes
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Notes supplémentaires dans les données
  • Cause
    Volcano corporation has initiated a voluntary recall of all lots of the device for pulling a single-use catheter trackback ii: code 91003. the trackback ii is intended for use with eagle eye® intravascular imaging catheters. the device provides stable and accurate movement of the catheter, which allows you to evenly collect image data. the recall is initiated by the company as a precautionary measure due to concerns about the integrity of the primary packaging, which may affect the sterility of the product after shipment. volcano corporation has not received any complaints about this and no reports of harm to the patient or his death caused by the use of the product. however, the company asks to immediately stop using the device in trackback ii and return unused devices to the distributor.

Device

Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging ...

Manufacturer

Volcano Corporation, USA
  • Société-mère du fabricant (2017)
    Philips
  • Source
    MHRB