| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00113-1 |
| Product Name/Description |
Allura Xper FD20 Biplane / FD20 Biplane OR table (Flouroscopic angiographic digital x-ray system)
Software versions prior to 8.1.0.3 are affected
Product Codes: 722013 & 722025
ARTG number: 175708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
If using the Targano wheel or speed slider to increase the image speed during the replay of a vascular Biplane run, with different image sized on disk in the Frontal and Lateral channel (1024x1024 or 2048x2048), an Image Processing error will occur resulting in a system hang up. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising the customers that until the corrective action has been implemented, the Targano wheel or speed slider should not be used to effect the image speed during replay of a vascular bi-plane run. Philips is providing a software upgrade (v 8.1.0.3) to correct the issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |