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SOFTWARE FOR LIFECYCLE FOR PRENATAL SCREENING (2016-04-01)
- Starting date:
- April 1, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58026
Affected products
A. SOFTWARE FOR LIFECYCLE FOR PRENATAL SCREENING
Reason
Manufacturer became aware that the latest software version has an incorrectly defined calculation parameter in one of the proportion equations for ductus venosus pulsatility index (DVPI).
Affected products
A. SOFTWARE FOR LIFECYCLE FOR PRENATAL SCREENING
Lot or serial number
v4.0
v4.0 Rev. 2
v4.0 Rev. 3
v4.0 Rev. 4
Model or catalog number
5014-0020
Companies
- Manufacturer
-
Wallac Oy
Mustionkatu 6, P.O. Box 10
Turku
20750
FINLAND