Events

Alerte De Sécurité sur Styker’s Berchtold F-generation LED lights

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

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
    2014-11-04
  • Date de publication de l'événement
    2014-11-04
  • 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/recalls_20141104.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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: medtronic styker’s berchtold f-generation led lights medical device manufacturer, medtronic, has issued a field safety notice (fsn) concerning certain styker’s berchtold f-generation led lights with affected model numbers of f528 (with a serial number smaller than 831800001526) and f628 (with a serial number smaller than 831710002819). there is the potential for electromagnetic interference (emi) between medtronic’s stealthstation axiem or fusion em technology and the abovementioned models of styker’s berchtold f-generation led lights. when the lights are positioned according to berchtold’s instructions for use – at a distance at least one meter from the patient – there is no interference. when the lights are positioned closer to the patient, the resulting emi causes the stealthstation axiem or fusion em system to cease tracking and display “red status”, which prevents navigation until the emi is removed. the testing confirmed that the stealthstation axiem/fusion system meets specification. if users have the devices with one of the affected serial number ranges above, they should consider limiting use of the axiem or fusion em system to rooms that do not have these lights installed. if no alternative room is available, customers are reminded to ensure use of the lights according to the berchtold instruction for use, maintaining a light head position at least one meter from the surgical site. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2014.

Device

Styker’s Berchtold F-generation LED lights
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Styker’s Berchtold F-generation LED lights
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH