| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00411-1 |
| Product Name/Description |
Philips Model AFFINITI 50 Ultrasound System
(Intended for diagnostic ultrasound imaging and fluid flow analysis)
Software Versions 1.0.2 or lower
ARTG Number: 93851 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
When AFFINITI 50 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).
When using both height and weight to calculate the BSA, which is the usual practice for patients above the age of 2 years, the result may be too high by a factor of about 10, an error that would be readily identified by the user.
Using patient’s weight only to calculate the BSA 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. |
| 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 until the software is implemented. This action has been closed-out on 05/09/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |