| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00169-1 |
| Product Name/Description |
MAC VU360 V1.02 SP05 12 Lead ECG Post Acquisition Preview Screen
Product number: 2030360-001
GTIN: 00840682125499
ARTG 362792
(GE Healthcare Australia Pty Ltd - Interpretive multichannel electrocardiograph) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
On the MAC VU360 software version V1.02 SP05, after performing a 12 Lead ECG Acquisition, a filter is applied post-acquisition on the Preview Screen or Print Out report. There is the potential that the amplitude could be slightly reduced for QRS waves.
A new software version MACVU360 1.02 SP06 has been released to fix the reported issue on affected devices. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers can continue to use your MAC VU360 system because the 12SL algorithm measurements remain accurate and will indicate ventricular hypertrophy in the interpretive statement if present, even if the displayed filtered QRS waveform is slightly reduced.
A GE HealthCare representative will contact customers to arrange for the correction after receiving the customer response form.
After the MAC VU360 has been updated customers must discontinue usage of and destroy any media containing MAC VU360 V1.02 SP05 and any prior versions of MAC VU360 software. |
| Contact Information |
1800 659 465 - GE HealthCare Service |