Vivid 7 Dimension Ultrasound System, Vivid E9 Ultrasound System, Vivid E95 and Vivid E90 (2018-03-28)
- Starting date:
- March 28, 2018
- Posting date:
- April 24, 2018
- 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-66540
Affected products
- Vivid 7 Dimension Ultrasound System
- Vivid E9 Ultrasound System
- Vivid E95
- Vivid E90
Reason
The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. This can lead to injuries up to and including cardiac arrhythmia or cardiac arrest. A minor injury has been reported as a result of this issue.
Affected products
-
Vivid 7 Dimension Ultrasound System
Lot or serial number
Not applicable
Model or catalog number
H45531YZ/YD/YR/YT/YX
Companies
- Manufacturer
-
GE Vingmed Ultrasound AS,
Strandpromenaden 45, P.O. Box 141,
Horten
3191
NORWAY
B. Vivid E9 Ultrasound System
Lot or serial number
Not applicable
Model or catalog number
H45561GJ
H45571LS
Companies
- Manufacturer
-
GE Vingmed Ultrasound AS,
Strandpromenaden 45, P.O. Box 141,
Horten
3191
NORWAY
C. Vivid E95
Lot or serial number
Not applicable
Model or catalog number
H45581DA
Companies
- Manufacturer
-
GE Vingmed Ultrasound AS,
Strandpromenaden 45, P.O. Box 141,
Horten
3191
NORWAY
D. Vivid E90
Lot or serial number
Not applicable
Model or catalog number
H45581LB
Companies
- Manufacturer
-
GE Vingmed Ultrasound AS,
Strandpromenaden 45, P.O. Box 141,
Horten
3191
NORWAY