| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00407-1 |
| Product Name/Description |
Philips Model EPIQ 7 Ultrasound System with Pediatric Cardiology option
(Intended for diagnostic ultrasound imaging and fluid flow analysis)
Software versions 1.3.2 or lower
ARTG Number: 93851 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
When EPIQ 7 Ultrasound System is set up to ‘Metric’ and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient’s Body Surface Area (BSA).
Using patient’s weight only to calculate the BSA, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. A Cardiac Index calculated using that value would be too low by a factor of 1.7. An error of this magnitude may not be readily detected by the user.
Alternatively, when using weight only the BSA may be out by a factor of about 1.7 which is much harder to detect as a Cardiac Index calculated using that value may not be as obvious to the user. However it is highly unlikely that this type of calculation would be used for patients older than 2 years of age.
Therefore, the risk of this error occurring is greatest when the BSA is calculated using weight only in patients under 2 years of age. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has corrected this issue in software version 1.3.3. which will be provided to users free of charge. This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |