| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00411-1 |
| Product Name/Description |
Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 when used with probes C1-5-D, C2-9-D, IC-5-9-D and M5Sc-D
ARTG Number: 146317 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (C1-5-D, C2-9-D, IC5-9-D and M5Sc-D) are incorrect. This may result in a situation where probes can overheat. If a certain specific hardware failure occurs on the Vivid E9 transmitter board (GTX192) this may, in combination with the incorrect power surveillance settings mentioned above, result in an overheating of the probe surface on the listed probes. No overheating of the probes listed above has been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE is requesting their customers to cease using the IC5-9-D probe until the systems have been corrected. If any other prodes are observed to be over heating customers should discontinue using the Vivid E9 system and contact GE immediately. |
| Contact Information |
1800 659 465 - GE Healthcare Nation Call Centre |