Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00392-1 |
Product Name/Description |
Philips Model EPIQ 5 Ultrasound System with Versions 1.3.2 or lower with Paediatric Cardiology option
ARTG Number: 93851 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
12/05/2015 |
Responsible Entity |
|
Reason/Issue |
When EPIQ 5 Ultrasound System is set up to ‘Metric’ and weight and/or height is entered, a unit conversion error may occur which results in the incorrect calculation of the patient’s Body Surface Area (BSA).
When using both height and weight to calculate the BSA which is the usual practice for patients above the age of 2 years an error factor of about 10 may be applied which would be readily identified 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 the 12/10/2018. |
Contact Information |
1800 251 400 - Philips Customer Care Centre |