| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00898-1 |
| Product Name/Description |
Allura Xper FD20 R8.2
System Code: 722028
Serial Number: 460
ARTG Number: 225815 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that the Protecting Earth (PE) cable between a motion controller and the PE star point was not installed on the affected product.
The lack of this aforementioned protective earth cable makes the system not compliant with the IEC60601-1 standard for protective earthing, however there is no risk for patients / operators / users since the frame is connected to protective earth (PE) and the unit involved is shielded with a cover.
The relevant parts are in the technical (equipment) room and therefore not accessible for patients. To date, Philips is not aware of any injuries that may have occurred as result of this situation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is requesting customers:
1. Read the supplied notice;
2. Place the notice with the documentation of the system until this correction has been implemented; and
3. Complete the supplied response form and return it to Philips via fax/email within 3 business days of receiving the customer letter.
This action has been closed out on 12/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |