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