| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01162-1 |
| Product Name/Description |
Allura Xper R9 and Azurion R1.1 systems with the QA Basic Measurement tool
Product Names: Allura Xper R9 7M20, Azurion 7M12, Azurion 7M20
ARTG Number: 225815 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified when using the downscale option, the measurements performed with the Allura R9 or Azurion R1.1 systems (using QA Basic Measurement tool) will not be correctly exported to the external DICOM destination. The difference between the original & exported measurements can vary, and the distance value after export is factor 1 to 4 smaller than the original. The difference will depend on the acquired image & used archive settings. If the measurement is re-performed at the external DICOM destination, the result will also be incorrect unless a recalibration of the image is executed. If these exported downscaled images are used during/in preparation of a procedure, the incorrect measurement values could result in the selection of an incorrectly sized device. The same applies if a measurement is re-performed at the external DICOM destination without executing a recalibration of the image.
To date Philips is not aware of any injuries that may have occurred due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. The Downscale option should be disabled in all Export protocols until Philips corrects this issue.
2. Distribute the notice to all users of the device.
3. Complete the supplied response form and return it to Philips.
4. The problem will be resolved by a software update, which is expected to be available by the end of 2017.
5. Philips representatives will notify users when the software update is available for installation.
6. In the interim, a similar notice will be provided along with newly manufactured devices shipped for use.
This action has been closed out on the 03/12/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |