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Spectra Optia Apheresis System - Main Unit
- Starting date:
- May 1, 2017
- Posting date:
- June 7, 2017
- 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-63508
Reason
A power filter cable, a component used in the internal electrical system, had a visible defect which caused the unit to lose power. Further evaluation determined that this defect may be present in other electrical cables which could cause a similar non-recoverable power failure. The cables have been isolated to specific manufacturing lots
Affected products
Spectra Optia Apheresis System - Main Unit
Lot or serial number
1P04028 to 1P04392
Model or catalog number
61000
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
Colorado
UNITED STATES