Events

Recall of PALMSAT PULSE OXIMETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NONIN MEDICAL 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
    66443
  • Event Risk Class
    II
  • Event Initiated Date
    2008-04-30
  • 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
    Incorrect label- the label on the back of the device may show model 2500a rather than model 2500 where 'a' indicates the device has alarm functions.

Device

PALMSAT PULSE OXIMETER
  • Model / Serial
    Model Catalog: (Lot serial: 500218376); Model Catalog: (Lot serial: 500222555); Model Catalog: (Lot serial: 500222564); Model Catalog: (Lot serial: 500222578); Model Catalog: (Lot serial: 500222524); Model Catalog: (Lot serial: 500222526); Model Catalog: (Lot serial: 500218362); Model Catalog: (Lot serial: 500218363); Model Catalog: (Lot serial: 500218364); Model Catalog: (Lot serial: 500218366); Model Catalog: (Lot serial: 500218369); Model Catalog: (Lot serial: 500218370); Model Catalog: (Lot serial: 500218373); Model Catalog: (Lot serial: 500222543); Model Catalog: (Lot serial: 500222553)
  • Product Description
    PALMSAT PULSE OXIMETER
  • Manufacturer
    NONIN MEDICAL INC.

Manufacturer

NONIN MEDICAL INC.