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Vitrea2 and Vitreacore Software DVD (2013-10-21)
- Starting date:
- October 21, 2013
- Posting date:
- November 29, 2013
- 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-36909
Recalled Products
A. Vitrea2
B. Vitreacore Software DVD
Reason
Found during in-house testing - incorrect image orientation may occur when loading a study into the 3D viewer in Vitreacore, taking a 16-bit secondary capture snapshot and loading this in a Dicom viewer. Orientation markers displayed in a Dicom viewer may be incorrect.
Affected products
A. Vitrea2
Lot or serial number
Vitreacore 6.0
Vitreacore 6.1
Model or catalog number
VPMC-11907
VPMC-12323
Companies
- Manufacturer
-
Vital Images
Inc.
5850 Opus Parkway
Minnesota
UNITED STATES
B. Vitreacore Software Dvd
Lot or serial number
Vitreacore 6.2
Vitreacore 6.3
Vitreacore 6.4
Vitreacore 6.5
Model or catalog number
VPMC-12193
VPMC-12256
VPMC-12327
VPMC-12398
VPMC-12511
VPMC-13023
Companies
- Manufacturer
-
Vital Images
Inc.
5850 Opus Parkway
Minnesota
UNITED STATES