Events

Recall of RAINBOW REUSABLE SENSORS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHYSIO-CONTROL CANADA SALES 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
    46956
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-21
  • 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
    Masimo has identified specific lots of sensors that were manufactured with incompatible configurations. this could result in sensors that will either not provide readings for the spco and spmet parameters or inaccurate readings. the specific behavior will depend on the firmware version of the technology board in the device. spco measurements when displayed could be incorrectly elevated throughout the measurement range. spmet measurements above 6% could be affected by a negative bias of 1.5% on average.

Device

RAINBOW REUSABLE SENSORS
  • Model / Serial
    Model Catalog: 2696 (Lot serial: BOX LOT 15HA6); Model Catalog: 2696 (Lot serial: BOX LOT # 15JA8); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15H754); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15G760); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15J824); Model Catalog: 2696 (Lot serial: Sensor Ref#/LOT# 24087-A15H754); Model Catalog: 2696 (Lot serial: Sensor Ref#-LOT# 24087-A15J726)
  • Product Description
    Rainbow Reusable Sensors
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC