Events

Recall of PHOTOTHERAPY 4000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA INC..

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
    126877
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-18
  • 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
    A routine internal quality check has found that the pt 4000 is fitted with a 16 amp fuse instead of the specified 1.6 amp rating. this may mean that the internal fuse does not trip promptly in the event of an internal short-circuit with the possible consequence that the ward panel circuit-breaker may be tripped first or the device may severely overheat.

Device

PHOTOTHERAPY 4000
  • Model / Serial
    Model Catalog: 2M 21700 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    PHOTOTHERAPY UNIT PT 4000 FOR NEONATES/INFANTS
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.