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SPECTRA OPTIA APHERESIS SYSTEM (2015-08-31)
- Starting date:
- August 31, 2015
- Posting date:
- September 29, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55132
Recalled Products
A. SPECTRA OPTIA APHERESIS SYSTEM
Reason
The risk of a data entry error on the Spectra Optia system that can lead to a safety issue, and the actions required to mitigate the risk. This issue can occur if the operator enters the incorrect patient height and/or weight when entering the data on the system.
Affected products
A. SPECTRA OPTIA APHERESIS SYSTEM
Lot or serial number
All lots.
Model or catalog number
61000
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
Colorado
UNITED STATES