Events

Recall of OMNIDIAGNOST ELEVA

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
    75334
  • Event Risk Class
    II
  • Event Initiated Date
    2016-08-18
  • 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 healthcare has discovered through customer feedback a system restart failure as a result of a blown fuse. the fuse was blown due to an unexpected main power failure in the hospital in which the uninterruptible power supply (ups) took over. philips discovered after internal investigation that in time the fuse degrades. the degrading depends on the initial value of the fuse the current through the fuse a continuous high operating temperature the environmental temperature and the time the system is operational. after degradation the blowing of the fuse may be triggered by an unexpected main power failure as described above.

Device

OMNIDIAGNOST ELEVA
  • Model / Serial
    Model Catalog: 708027 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 000454 (Lot serial: 33); Model Catalog: 000454 (Lot serial: 146); Model Catalog: ALLURA XPER FD20/20 (Lot serial: 171); Model Catalog: ALLURA XPER FD20 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 0708MD02 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ALLURA XPER FD20/20 (Lot serial: 607); Model Catalog: ALLURA XPER FD10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 168); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 37); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 57); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 567); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 52); Model Catalog: ALLURA XPER FD20/10 (Lot serial: 283); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 154); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 307); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 40); Model Catalog: ALLURA XPER FD10/10 (Lot serial: 306); Model Catalog: ALLURA XP
  • Product Description
    OMNIDIAGNOST ELEVA;ALLURA XPER FD20 OR TABLE;ALLURA XPER FD20/20;ALLURA XPER FD20 SYSTEM - MAIN UNIT;MULTIDIAGNOST ELEVA - FLAT DETECTOR - IMAGE DETECTOR;ALLURA XPER FD10;MULTIDIAGNOST ELEVA - IMAGE INTENSIFIER - TV IMAGE DETECTOR;ALLURA XPER FD20/10 SYST
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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