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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00924-1
Product Name/Description Spectra Optia Apheresis System

All Serial Numbers

ARTG number: 130529
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/09/2012
Responsible Entity Terumo BCT Australia Pty Ltd
Reason/Issue The manufacturer has become aware that the Spectra Optia System's Return Line Air Detector (RLAD) can potentially fail as a result in a non-continuable alarm condition. If air has been falsely detected due to a defective RLAD during a procedure, a continuous "Air detected in Return Line" alarm will occur and will not allow the procedure to continue. If the RLAD experiences a defect during prime, the system will generate a "Return Line Air Detector failed fluid check" alarm and will not allow the procedure to be performed until serviced.
Recall Action Recall for Product Correction
Recall Action Instructions Terumo BCT is providing work around instructions for users to follow.
Contact Information 1300 553 507 - Terumo BCT Office