| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01011-1 |
| Product Name/Description |
EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imaging
and fluid flow analysis)
ARTG Number: 93851 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
A problem has been detected with Philips Model EPIQ 7 Ultrasound System V1.0 when using Philips QLAB a2DQ software feature. It is possible to have erroneous ejection fraction (EF) measurements appear in the biplane analysis report page under certain conditions while using a2DQ. The biplane analysis report page could display AP2 or AP4 EDV/ESV/EF measurements from a prior patient’s exam. Erroneous measurement information in the biplane analysis report page could mistakenly influence patient care. This issue only occurs on software version 1.0 in a2DQ during a live (frozen) image and only when a single biplane view is included in the exam. When both biplane views are present (AP2 and AP4) this issue does not occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips corrected this issue in Version 1.01 of the EPIQ 7 Ultrasound System. A Philips Field Service Engineer will be contacting customers to schedule the V1.01 upgrade to affected systems. Philips is providing temporary workaround instructions to prevent the failure mode from occurring until the systems are upgraded. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |