Events

Field Safety Notices about ventilator Philips V60

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Respironics California, LLC.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-04-20
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Respironics california, llc ("respironics") voluntarily performs a patch for any non-invasive philips v60 fan made before september 15, 2015, requiring replacement of the internal fan cable. respironics started distributing v60 fans in 2009. all v60 models made before september 15, 2015 are subject to this revision. v60 fans manufactured on or after september 15, 2015 have a different internal cable, so this correction does not apply to them and there is no need to do anything about them.

Device

ventilator Philips V60

Manufacturer

Respironics California, LLC
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AMPMDRS