Events

Recall of ALLURA XPER FD10/10 - MAIN UNIT

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
    143084
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-28
  • 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 that extra monitors so called 7th or 8th monitor mounted on the monitor ceiling suspension (mcs) might disengage from the mcs and fall down. the two small set screws securing the two gliding rods into an aluminum block of the support arm can come loose because of vibrations and forces exerted on them. if the set screws have come loose gravity can keep the rods in position. however if a force is exerted on the monitor pushing it forward the monitor can topple forward. once the monitor has toppled over it is only attached with its wires. if the monitor breaks loose of its wires it will drop on the floor. see e-file for french translation.

Device

ALLURA XPER FD10/10 - MAIN UNIT
  • Model / Serial
    Model Catalog: ALLURA XPER FD10/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20/20 (Lot serial: N/A); Model Catalog: ALLURA XPER FD10 (Lot serial: N/A); Model Catalog: ALLURA XPER FD20 (Lot serial: N/A); Model Catalog: 000454 (Lot serial: N/A)
  • Product Description
    ALLURA XPER FD10/10 - MAIN UNIT;ALLURA XPER FD20/10 SYSTEM-MAIN UNIT;ALLURA XPER FD20/20;ALLURA XPER FD10;ALLURA XPER FD20 SYSTEM - MAIN UNIT;ALLURA XPER FD20 OR TABLE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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