| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00390-1 |
| Product Name/Description |
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 63.0
Vivid S70N/S60N with software version 201, revision 63.0
ARTG Number: 146317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed-out on 27/03/2018. |
| Contact Information |
1800 659 465 - GE National Call Centre |