Events

Recall of INGENUITY CT SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    130773
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-17
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware of the following issues: - slab viewer longitudinal location issue - it is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. the following key events must take place for harm to occur: -the patient is placed in a "feet-first" orientation. -an interventional ct procedure is scheduled. -contrary to typical clinical practice a multi-planar reconstruction (mpr) is used for planning the interventional procedure (this issue only occurs in images produced using mpr). -a check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure). -the needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location). - fast get ready issue - fast get ready incorrectly enabled during service procedures. - contrast annotation issue - contrast annotation incorrectly missing for some images when manual contrast was administered. - dot artifact issue - dot artifact present intermittently after startup. - heart rate update issue - heart rate measured value incorrectly remains constant for some heart rate change conditions. - doseright issue - doseright incorrectly enabled when the exam card specified disabling doseright. - tube heat issue - tube heat predictor fails to warn of overheat condition for long scans.

Device

INGENUITY CT SYSTEM
  • Model / Serial
    Model Catalog: 728326 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL)
  • Product Description
    INGENUITY CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC