| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00995-1 |
| Product Name/Description |
Allura Xper FD Release 8.2.16
(Flouroscopic x-ray used in angiography)
ARTG Number: 175708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has discovered through customer feedback and internal testing a software failure that could lead to an intermittent and short term unavailability of the Fluoroscopy function.
Upon initiating Fluoroscopy the user may encounter a user message “Fluoro failed, please retry” and Fluoroscopy will be unavailable. Retrying Fluoroscopy resolves this situation in most cases. You may need to retry more than once in about 2% of the events.
The failure mode has no impact on an active Fluoroscopy run. Once started, an active Fluoroscopy run continues until releasing the pedal. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising end users that they must retry fluoroscopy if the failure mode occurs. Philips Field Service Engineers will install Software R8.2.16.1 which will correct the issue. The expected date of the correction release is October 2015. This action has been closed-out on 26/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |