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Health product recall

Vivid E9 Ultrasound System (2013-10-02)

Starting date:
October 2, 2013
Posting date:
October 25, 2013
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-36385

Recalled products

A. Vivid E9 Ultrasound System 

Reason

The Vivid E9 scanner may gradually become unresponsive and eventually lock up during a time critical procedure. The vivid E9 scanner would need to be rebooted. This event may lead to possible risk to patients when performing transesophageal echocardiography in an interventional environment.

Affected products

A. Vivid E9 Ultrasound System 

Lot or serial number

Not applicable

Model or catalog number
  • H45561RT
  • H45561RX
Companies
Manufacturer
GE Vingmed Ultrasound AS,
Strandpromenaden 45, P.O. Box 141,
Horten
3191
NORWAY