Events

Recall of TOTALCARE SPO2RT 2 SURFACE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HILL-ROM CANADA 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
    92029
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-01
  • 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
    This field correction is being initiated by hill-rom due to a potential hazard occurring on the totalcare spo2rtr 2 surface at a rate above what hill-rom expects.

Device

TOTALCARE SPO2RT 2 SURFACE
  • Model / Serial
    Model Catalog: P1918B (Lot serial: NA)
  • Product Description
    TOTALCARE SPO2RT 2 SURFACE
  • Manufacturer
    HILL-ROM CANADA LTD.

Manufacturer

HILL-ROM CANADA LTD.