Events

Recall of Cleveland CT

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
    22197
  • Event Initiated Date
    2017-11-06
  • 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 manufacturer has become aware of a potential problem with our philips brilliance 64/ ingenuity family version 4.1.6 as detailed below:, issue 1: cardiac signal not found in workflow issue, issue 2: scan may start at the top of the head, which may not be where the operator is expecting the scan to start, issue 3: pulmo gates on cardiac workflow issue, issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well., issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results, issue 6: application may fail when modifying the results plan box during 3d calcium score, issue 7: tube too hot, issue 8: memory overflow issue, issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message, issue 10: issue with the generatormonitor state machine in rhost code issue.
  • Action
    Manufacturer to issue advice regarding use

Device

Cleveland CT
  • Model / Serial
    Model: , Affected: The following CT(Computed Tomography) systems are affected: Brilliance 64 728231, Ingenuity Core128 728323, Ingenuity CT 728326, Software version: Running software version: 4.1.6
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

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