Events

Recall of Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX8000 Dual, MX8000 Dual EXP, MX8000 IDT and MX8000 IDT 10

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 (USA).

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
    15027
  • Event Initiated Date
    2013-07-19
  • 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
    The ct system phantom supplied with the above-listed scanners has a special pin by which the customer can check the low contract (lc) detectability for quality assurance. this pinconsists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon., the lc test is performed by visually inspecting the sectionand selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use. the manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable., the pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates the test becomes unreliable and inaccurate.
  • Action
    Instructions for use to be updated

Device

Philips Briiliance (BR) CT 16-Slice, BR CT 10-Slice Water, BR CT 6-Slice Water, MX8000 Quad, MX80...

Manufacturer

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