| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00491-1 |
| Product Name/Description |
Ultrasound Q-Station version 3.0 or higher
ARTG Number: 100468 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
If a user opens a study for review on Q-Station before its transfer from the Ultrasound system cart has completed, measurements from that study (Structured Report) may be appended to subsequent studies for other patients.
As a result, measurements from one patient may be presented in another patient’s study, due to a failure to clear previous patient information when selecting the new study.
This hazardous situation will exist only if all of the following events occur:
A user performs and completes a study (study A) on the Ultrasound system that includes SR (Structured Report) measurements and initiates the export of study A to Q-Station (‘manual’, ‘auto’ or ‘send as you scan’).
The user opens study A for review On Q-Station using view/report/export before the transfer of the SR is complete. No reports of misdiagnosis or harm as a result of the data mixing have been received. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has corrected this issue via software version 3.3.2 and is sending a CD with this latest version of Q-Station to the affected customer, free of charge. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 Phillips Customer Care Centre |