| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00071-1 |
| Product Name/Description |
Allura Xper Systems with an attached 7th or 8th monitor
Multiple System Codes
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 |
19/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has been made aware of a mounting issue with the 7th or 8th monitor to the Monitor Ceiling Suspension. The 7th or 8th monitor attached to the Monitor Ceiling Suspension may disengage from the suspension arm and fall down.
Only Allura Xper systems with an attached 7th or 8th monitor on the Monitor Ceiling Suspension are affected.
When a 7th or 8th monitor disengages from the suspension arm it could pose a risk for the patient, user, bystander or service engineer. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips will be in contact with all potentially affected users and arrange for the set screws to be secured.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |