Spectra Optia™ Apheresis System-main Unit Software V 12.1

Recall Summary Terumo BCT, Inc. is recalling Spectra Optia™ Apheresis System-Main Unit Software V 12.1 due to a device performance issue. The software is used in apheresis systems, which are medical devices that collect and separate blood components. This recall affects units distributed across Canada.

Recalling firm
Terumo BCT, Inc.
Product
Spectra Optia™ Apheresis System-Main Unit Software V 12.1
Reason
Device performance issue
Classification
Class II
Category
medical device recall
Country
Canada
Agency
HC-DEVICES
Recall date
2026-11-12
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/0162c2e4-3f55-462b-ae46-34cee0fb20d2