| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00796-1 |
| Product Name/Description |
Allura Xper
Allura software versions: 8.1.25; 8.1.25.1; 8.1.25.5; 8.2.25; 8.2.25.5; and 8.2.27
ARTG Number: 225815
(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips have identified that the first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising this issue will be resolved in a software update, expected to be available in the second half of 2018. Philips will notify users when this software update is available.
Until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor.
This action has been closed out on 31/07/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |