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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00379-1
Product Name/Description	Masimo Rad-8 Pulse Oximeters Manufactured from March 27, 2009 to January 24, 2013 Device Identifiers: 1844, 1959, 1961, 1963, 22042, 22595, 3446, 9019, 9049, 9073, 9165, 9174, 9190, 9212, 9224,1845, 1960, 1962, 1964, 9020, 9050, 9074, 9166, 9175, 9191, 9213, 9192, 9194, 9193, 9195 ARTG Number: 138873
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/04/2013
Responsible Entity	Masimo Australia Pty Ltd
Reason/Issue	Masimo has identified a very small number of Rad-8 devices that, when moved, can power off without the operator pressing the power button. If a change in power status goes unnoticed by the caretaker, a delay of care could result. This recall action was not notified to the TGA before it was initiated by Masimo Australia.
Recall Action	Recall for Product Correction
Recall Action Instructions	Masimo is providing two options to the customers for correction and removal. The first option is to return the Rad-8 devices for Masimo for repair. The second option is for a biomedical engineer employed by a customer to repair the device in the field once qualified by Masimo to do so. This action has been closed-out on 11/02/2016.
Contact Information	02 9452 4334 (option 2) - Masimo Technical Services