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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01074-1
Product Name/Description	Rainbow Reusable Sensors for rainbow SET Devices with SpCO, SpO2, and SpMet. (used with pulse oximeter for the measurement of parameters such as arterial oxygen). Reference: 2696 Lot Number: 15HA6 Sensor Reference: 24087-A15G760 , 24087-A15H754 ARTG Number: 157503
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/11/2015
Responsible Entity	Masimo Australia Pty Ltd
Reason/Issue	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 behaviour 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.
Recall Action	Recall
Recall Action Instructions	Masimo is advising users to inspect stock and quarantine any affected units for replacement with unaffected stock. This action has been closed-out on 18/08/2016.
Contact Information	1800 326 4890 - Option 2 - Masimo Technical Services