Health product recall

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

Brand(s)
Last updated

Summary

Product
Spectra Optia™ Apheresis System-Main Unit Software V 12.1
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.  

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

1P03301

61000

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

1P09736

61000

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

1P09340

61000

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

1P02484

61000

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

1P09737

61000

Spectra Optia™ Apheresis System-Main Unit Software V 12.1

1P01464

61000

Issue

Customer notification for Spectra Optia Systems running software version 12.1 is intended to ensure awareness of the issue and support informed software management decisions. The general patient population being treated with plasma exchange is unlikely to experience issues with the AIM system. The population at greatest risk can experience a delay in treatment if the aim system cannot be disabled.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Terumo BCT, Inc.

10811 W. Collins Avenue, Lakewood, Colorado, United States, 80215

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82950

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