Events

Recall of PRONTO 7 (PDC SC) REUSABLE SENSOR

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
    142083
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-22
  • 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
    When performing an sphb measurement in cold conditions the pronto-7 rainbow reusable sensor may incorrectly measure actual finger temperature. as a result pronto-7 spot check pulse co-oximeter may provide an incorrect sphb measurement.

Device

PRONTO 7 (PDC SC) REUSABLE SENSOR
  • Model / Serial
    Model Catalog: 2953 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2952 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2920 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 9147 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2954 (Lot serial: All serial #s from A83F90 & up); Model Catalog: 2951 (Lot serial: All serial #s from A83F90 & up)
  • Product Description
    PRONTO 7 (PDC SC) REUSABLE SENSOR
  • Manufacturer
    MASIMO CORPORATION

Manufacturer

MASIMO CORPORATION