Health product recall

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

  1. Vivid 7 Dimension Ultrasound System
  2. Vivid E9 Ultrasound System
  3. Vivid E95
  4. 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

  1. 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