Quality & complianceOfficial

Health Canada lists Type II recall of Terumo BCT Spectra Optia software version 12.1

🇨🇦 Health Canada · Thu 12 Nov 2026

Terumo BCT has notified customers using Spectra Optia apheresis systems on software 12.1, with Health Canada noting a possible treatment delay if the AIM system cannot be disabled.

Health Canada has published a Type II recall for the Spectra Optia Apheresis System main unit software version 12.1, made by Terumo BCT, Inc. of Lakewood, Colorado. The recall is recorded under identification number RA-82950 and carries a recall date of 2 November 2026. The notice was last updated on 12 November 2026.

The issue is categorised as a medical device performance problem in the haematology category. The audience is healthcare. Six lots or serial numbers are listed, all under model or catalogue number 61000: 1P03301, 1P09736, 1P09340, 1P02484, 1P09737 and 1P01464.

According to the notice, the manufacturer's customer notification is meant to make users aware of the issue and to support informed decisions on software management. Health Canada says the general patient population treated with plasma exchange is unlikely to experience problems with the AIM system. The population at greatest risk could face a delay in treatment if the AIM system cannot be disabled.

The notice gives no further technical detail on the underlying fault. Its only instruction is that anyone needing more information should contact the manufacturer. As general context, a Type II recall in Canada covers products that may cause temporary or medically reversible adverse effects, or where the likelihood of serious harm is remote.

What it means for your team

  • Hospital and apheresis-unit teams in Canada should check whether any Spectra Optia main units running software 12.1 match the six listed lots or serial numbers under model 61000.
  • Quality and device-vigilance staff should obtain the manufacturer's customer notification, since the Health Canada entry offers little technical detail.
  • Clinical engineering teams should identify which patient groups depend on the ability to disable the AIM system, as the notice links the highest risk to treatment delay when it cannot be disabled.
  • Regulatory teams with devices or software of this type should note that the recall is classed as Type II.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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