| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00335-1 |
| Product Name/Description |
Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software
ARTG number: 170658 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications to calculate End-Systolic Volume (ESV), the reported ESV may be smaller than the ESV calculated by manual tracing without the use of QLAB. Correspondingly, the Left Ventricular Ejection Fraction (EF) calculated using these applications may be higher than the EF calculated by manual tracing without the use of QLAB. Philips’ investigation has found that this difference may occur in cases where the EF is less than approximately 40%.
An incorrect Ejection Fraction calculation could lead to misdiagnosis and/or delayed or incorrect therapy if healthcare providers make clinical decisions based solely on these measurements, without considering other available clinical data. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing temporary work instructions for users to follow until a software upgrade to QLAB Version 10.2 or higher is completed. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |