Events

Recall of DIGITAL DIAGNOST

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
    27718
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-13
  • 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 an issue in the m-cabinet of the digitaldiagnost. the creepage distance between the two primaray phases in the geo transformer is 4.5mm. according to iec 60601-1 (2nd edition clause 57.10) the international standard governing electrical specifications for electronic products the creepage distance for a 500v ac (as found in the m-cabinet)has to be 5.5mm.

Device

DIGITAL DIAGNOST
  • Model / Serial
    Model Catalog: 9890 010 8390X (Lot serial: 496371/SN12000057)
  • Product Description
    DIGITAL DIAGNOST
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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