| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01252-1 |
| Product Name/Description |
Philips Ultrasound QLAB versions 10 and 10.1 .x with a2DQ and/or aCMQ plug-ins
ARTG Number: 100468 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion DESCRIPTION Quantification (aCMQ) applications to calculate End-Systolic Volume (ESV), the reported ESV may be smaller than 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%. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing instructions to assist end users to determine if they are affected by this issue. Philips has developed a software update to correct the issue. A CD with the new version of the software will be sent to all end users for installation.
Until the software has been upgraded, the issue can be avoided by ensuring that left ventricular volumes and ejection fraction are calculated by using either the on-cart manual analysis package or off-cart manual analysis package for your primary assessment. This action has been closed-out on 1/06/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |