Events

Recall of Philips Angiographic X-Ray

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Philips Medical Systems Nederland BV.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    21265
  • Event Initiated Date
    2017-03-29
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Reason
    Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. if this occurs the liquid may drip onto electrical components in the r-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odour, smoke or fire.
  • Action
    Product to be modified

Device

Philips Angiographic X-Ray
  • Model / Serial
    Model: , Affected: Allura Xper and Allura CV20 Releases 3 to 8.1 with an installed Laird chiller, Allura Xper Release 8.2: only configurations FD10, FD10/10, FD20/10, FD20/20 have a Laird chiller
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

Philips Medical Systems Nederland BV
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    NZMMDSA