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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