| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00360-1 |
| Product Name/Description |
Philips EPIQ 5 Ultrasound System
ARTG Number: 93851 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
The EPIQ 5 will report incorrect Doppler velocities if users use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates.
While in High Pulse Repetition Frequency (HPRF) in ‘Display Zoom Velocity Scale’ using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. The erroneous values are reported on the reports page and in DICOM SR if exported and include the following velocities and calculations:
General Imaging, (GI)-
- Peak Systolic Velocity (PSV)
- End Diastolic Volume (EDV)
- Minimum Diastolic Velocity (MDV)
- Time Averaged Peak Velocity (TAPV)
- Time Averaged Mean Velocity (TAMV)
Affected GI Calculations:
- S/D (Ratio of Peak Systolic Velocity / Peak diastolic Velocity)
- Resistivity Index (RI)
- Pulsatility Index (PI) |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has corrected the issues in software version 1.1.2. Philips is advising their customers to not use HPRF in doppler mode until the affected system is upgraded to version 1.1.2. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |