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AW Volumeshare - Seno Advantage Software Option
- Starting date:
- September 18, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Assistive/Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15123
Reason
GE Healthcare has become aware that patient mismatch without a warning message could occur on Seno Advantage (SA) Workstations under the following circumstances:
1. New non-mammographic images for patient a are being received (for example, via the network) at the same time that mammographic images for patient a are displayed on the high-resolution black and white monitors.
2. The non-mammographic images are then selected and displayed on the color monitor.
3. Mammographic images from a different patient are then selected on the high-resolution black and white monitors.
Affected products
AW Volumeshare - Seno Advantage Software Option
Lot or serial number
> 10 Numbers, Contact manufacturer
Model or catalog number
5183685-X, 5183859-X
Companies
- Manufacturer
- GE Medical Systems SCS
AW Volumeshare - Seno Advantage Software Option
Lot or serial number
'00000193277GE1, '000004410002GS
Model or catalog number
5341143-X, 5342425-X
Companies
- Manufacturer
- GE Medical Systems SCS