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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00963-1
Product Name/Description	Spectra Optia Apheresis System with Software Version 11 Catalogue Number: 61000 ARTG Numbers: 130529
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/09/2014
Responsible Entity	Terumo BCT Australia Pty Ltd
Reason/Issue	A defect in Optia version 11 SW can cause an unexpected behaviour to the rinseback option when the WBC or platelet counts are updated during the run and they are sufficiently different from the previous counts. The absence of rinseback could result in loss of RBC potentially resulting in limited illness or injury. Unintended rinseback carried out on a very small patient could result in symptomatic hypervolemia. No serious injury or deaths have been associated with this behaviour.
Recall Action	Recall for Product Correction
Recall Action Instructions	Terumo BCT is actively working on a software update to correct this behaviour. Once this software is available affected devices will be updated. End users are being provided work around instructions to ensure the continued safe use of the device. This action has been closed-out on 14/07/2016.
Contact Information	02 9429 3600 - Terumo BCT Australia