| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00410-1 |
| Product Name/Description |
Philips Model AFFINITI 70 Ultrasound System Versions 1.0.2 or lower with Pediatric Cardiology option
(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 |
20/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
When Affiniti 70 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.
If a healthcare provider makes a clinical decision on the basis of a Cardiac Index calculated using an incorrect BSA without considering other indicators of cardiac function, misdiagnosis and/or delayed or incorrect therapy may result. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has corrected this issue in software version 1.0.3. which will be provided to users free of charge. Philips has provided work around instructions for end users to use until the software update is provided. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |