| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00599-1 |
| Product Name/Description |
Allura Xper and Azurion systems
Multiple model numbers
ARTG 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 |
3/07/2023 |
| Responsible Entity |
|
| Reason/Issue |
The wireless foot switch is used to control fluoroscopy and exposure with the Philips Allura Xper and Azurion systems.
Philips has become aware of several situations that can result in a loss of availability of the wireless foot switch during a procedure. Identified issues that may result in the wireless foot switch not being available are:
• Loss of Bluetooth connection due to interferences from other radio equipment
• Battery not fully charged
• Battery not holding its charge
• Damage in the charger, cable and/or connector of the wireless foot switch
If the wireless foot switch is not available during a procedure, there will be a delay in the procedure and potentially an abortion of the procedure.
To date, Philips has not received any reports of harm associated with any of the specific issues identified. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will contact users to schedule a Field Service Engineer visit, to confirm that the wired foot switch is connected to the system, perform a check of the charger, cable and/or connector of the wireless foot switch and provide a hardcopy of the addendum to the Instructions for Use and the Quick Reference Card. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |