Events

Recall of MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MASIMO CORPORATION.

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
    26269
  • Event Risk Class
    II
  • Event Initiated Date
    2005-07-05
  • 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
    The internal speaker could fail to produce an audio alarm during an alarm condition. the affected units were manufactured prior to december 11 2001.

Device

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE
  • Model / Serial
    Model Catalog: (Lot serial: P3027 through P3148); Model Catalog: (Lot serial: less than or equal to 102999)
  • Product Description
    SET Radical Handheld Pulse Oximeter
  • Manufacturer
    MASIMO CORPORATION

Manufacturer

MASIMO CORPORATION