Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19096
Brand Name:Terumo Spectra Optia Apheresis System
Model:Optia
Affected:All serial numbers
Software version:
Recalling Organisation:The Advisory Group Ltd
Level 9
55 Shortland St
Auckland 1010
Contact Information:
Manufacturer:Terumo BCT Inc
Issue:The manufacturer has received reports of data entry errors that cause the system to calculate a patient total blood volume (TBV) that is abnormal for that specific patient.
If the operator does not enter correct data the patient may receive excess anticoagulant (AC) or the outcome of the procedure may be affected.
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:4/9/2015
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