Alerte De Sécurité sur uninterruptable power supply batteries used with philips ct and molecular imaging systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips 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
    2015-03-24
  • Date de publication de l'événement
    2015-03-24
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: uninterruptable power supply (ups) batteries used with philips ct and molecular imaging systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning uninterruptable power supply (ups) batteries used with philips computed tomography and molecular imaging systems. the manufacturer has become aware of ups device failures that resulted in leaking of electrolyte (sulfuric acid), overheating and/or emission of fumes. analysis has identified that these failures are most likely due to batteries within the ups devices being held in service beyond their usable service life – typically three to five years. hazards involved as a result of ups devices failing include chemical burn, thermal burn and eye, nose and/or throat irritation. the manufacturer advises users to review the accompanying material and implement a ups maintenance programme at their facility as recommended by the manufacturer of their ups. to ensure continued safe and reliable performance from these devices, periodic maintenance is required - including possible battery replacement. the manufacturer has provided a ups information flyer outlining maintenance needs and a suggested maintenance strategy. according to philips healthcare, the concerned ups batteries are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 march 2015.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Uninterruptable Power Supply (UPS) Batteries used with Philips CT and Molecular Imaging Systems
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • Source
    DH