| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00837-1 |
| Product Name/Description |
Philips Ultrasound QLAB versions 10.0 and 10.1
Part Numbers: 453561704771 and 453561728001
ARTG Number: 100468 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0 and 10.1 when used on a picture archiving and communication system (PACS) or with third party PACS integration that could result in the erroneous calculation of Ejection Fraction (EF) from the results of a2DQ and aCMQ patient exams. An incorrect EF calculation could lead to misdiagnosis and/or delayed or incorrect therapy. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has corrected this issue in QLAB version 10.2, and is sending a CD with QLAB version 10.2 to affected customers.
Until your software can be upgraded to QLAB version 10.2, end users can avoid the issue by:
- Ensuring that a2DQ patient exams include both biplane views for AP2 and AP4. When both biplane views are present, EF measurements will not persist from measurements taken in a prior patient exam.
- Ensuring that aCMQ patient exams include all three views (AP2, AP3, and AP4). When all three views are present, measurements will not persist from measurements taken in a prior patient exam. This action has been closed-out on 03/06/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |