Events

Recall of Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and 61.0 Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here

Type of Event
Recall
Event ID
RC-2017-RN-00390-1
Event Risk Class
Class II
Event Initiated Date
2017-03-23
Event Country
Australia
Event Source
DHTGA
Event Source URL
https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00390-1
Notes / Alerts

Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
An issue has been identified whereby another patient other than the one intended is incorrectly selected by the operator in situations where dicom worklist search response time is slow. this issue is limited to certain vivid ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. if not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. this issue could lead to misdiagnosis. to date, there have been no injuries reported because of this issue.
Action
GE Healthcare is advising users to follow the "Safety Instructions" as detailed in their recall notification letter. Users are further advised that a GE Healthcare representative will contact them to arrange for a free correction of all affected products.

Device

Multiple Vivid Ultrasound Products Vivid E95/E90/E80 with software version 201, revision 54.0 and...

Model / Serial
Multiple Vivid Ultrasound ProductsVivid E95/E90/E80 with software version 201, revision 54.0 and 61.0Vivid S70/S60 with software version 201, revision 55.0 and 63.0Vivid S70N/S60N with software version 201, revision 63.0ARTG Number: 146317
Manufacturer
GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd

Manufacturer Parent Company (2017)
General Electric Company
Source
DHTGA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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