Events

Recall of Philips SENSE Body Coil 1.5T (used with ACS NT, Intera 1.5T, and Achieve 1.5T MR Systems)

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
    18767
  • Event Initiated Date
    2015-07-03
  • 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 instructions for use state how (and how not) to position the sense body coil 1.5t and its cables in relation to the patient and mr bore in order to avoid a hazardous situation. when these instructions are not followed during an examination, the positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to rf coupling to the quadrature body coil (qbc).
  • Action
    Product to be modified

Device

Philips SENSE Body Coil 1.5T (used with ACS NT, Intera 1.5T, and Achieve 1.5T MR Systems)
  • Model / Serial
    Model: 4522 131 5575x, 4522 132 1985x. 4522 132 7619x, 4598 000 5187x, 4598 000 5189x, 4598 003 590511 (where x can be a number from 1 to 9), Affected: All lots
  • Manufacturer
    Philips Medical Systems Nederland BV

Manufacturer

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