Terumo BCT's Spectra Optia software 12.1 drawn into Canadian recall

Terumo BCT, the Colorado-based maker of the Spectra Optia apheresis system, now has a regulatory entry in Canada against software version 12.1 of the machine's main unit. Health Canada recorded the action as RA-82950, with a recall date of 2 November 2026, and revised the notice on 12 November.

The listing covers six lots or serial numbers, all under catalogue number 61000: 1P03301, 1P09736, 1P09340, 1P02484, 1P09737 and 1P01464. Health Canada files the matter under haematology and classifies it as a device performance issue aimed at healthcare users.

The notice contains nothing on cost, replacement, sales impact or how many Canadian sites run the affected software. It does not say how the manufacturer plans to fix the problem. It says Terumo BCT has written to customers so they understand the issue and can make informed choices about managing the software.

On patient risk, Health Canada says people treated with plasma exchange are generally unlikely to be affected by the AIM system problem. The group at greatest risk could see treatment delayed if the AIM system cannot be switched off. The regulator gives no further explanation of the underlying fault and refers anyone wanting more to the manufacturer.

For context, Canada's Type II category applies to products that may cause temporary or medically reversible harm, or where serious harm is considered unlikely. Whether the action has wider commercial consequences for Terumo BCT cannot be judged from this entry.