Events

Recall of PROGRADE

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
    31840
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-16
  • 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 if the wifi connection between the skyplate detector and hp transfer point is weak an image may fail to transfer from the skyplate detector to the system. the image remains in the memory of the detector but cannot be transferred wirelessly or by use of the backup cable. to continue the operator can reset the skyplate detector by removing its batteries but the acquired image is lost and a re-take is necessary. (see e-file for french translation).

Device

PROGRADE
  • Model / Serial
    Model Catalog: 9897-010-01041 (Lot serial: N/A)
  • Product Description
    PROGRADE
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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