Events

Recall of JUNO DRF

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
    89865
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-25
  • 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 discovered that the system - in certain rare but possible combinations of user behavior (in zoom modes 30x30 and 15x15 only but not in other zoom modes and only in cases with manual override outside the operator's working location) - does not provide the appropriate audible signal permanent activation and manual override although the system is in high-level control functionality.

Device

JUNO DRF
  • Model / Serial
    Model Catalog: 9784729831 (Lot serial: 484993/SN11080854); Model Catalog: 9784729831 (Lot serial: 13121287)
  • Product Description
    JUNO DRF
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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