| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01085-1 |
| Product Name/Description |
EPIQ 7 Diagnostic Ultrasound System (software version 1.0, 1.0.1)
ARTG Number: 93851 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Under system settings, if the system date format is set to International, DD/MM/YYYY, the system continues to interpret the date as MM/DD/YYYY on the Patient Data Entry (PDE) screen. The anomaly exists in date fields for ‘Last Menstrual Period’ (LMP), ‘Established Due Date’ (EDD) and ‘Conception Date’. The LMP field is presented in four exam types: Obstetric (OB,) Fetal Echo, Gynaecology (GYN), and Breast and populates from one exam type to the other. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users that the issue can be avoided by making sure the system is set to the default setting of MM/DD/YYYY. A Philips Field Service Engineer will contact customers to schedule a software update to correct the issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |