| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00332-1 |
| Product Name/Description |
Discovery IGS 730
ARTG Number: 93871
(GE MEDICAL SYSTEMS, AUSTRALIA LTD X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of a potential loss of imaging mode during an interventional procedure using the Discovery IGS 730.
The Discovery IGS and Innova IGS systems may experience X-ray abort errors during a real-time interventional procedure. This issue could potentially happen before or during fluoroscopic use and could result in the loss of imaging capability.
To date, there have been no injuries reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare is advising that they will be in contact with affected users to arrange installation of the correction.
This action has been closed out on 11/02/2019 |
| Contact Information |
1800 659 465 - GE National Call Centre |