| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00881-1 |
| Product Name/Description |
Patient Support (NC989001087431) for X-Ray System
ARTG Number: 117662
(Philips Electronics Australia Ltd - X-ray system, diagnostic, general-purpose, stationary, digital) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
The footplate of the Patient support for stitching can be fixed in upper position. Philips has identified that when the fixing clamp (hook) is not in its correct locking position, the footplate is not securely held. If it falls down, it may hurt the operators or patient's foot or leg (e.g. when moving the stand or when the operator fails to fix it correctly upon moving the footplate up).
The following factors are needed for this situation to occur:
- Hinges are worn differently on both sides;
- Hook does not hold;
- The Operator does not check that the hook securely holds the footplate;
- The Footplate falls unexpectedly when touched or during transport;
- Foot or leg is in the “target area”; and/or
- Foot is in the “hazard area”. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising that they plan make the following design changes:
- Sturdier replacement hinges for floor plate;
- Install modified hook for floor plate (adapted to new hinges); and
- The brake cylinder below floor plate to minimise kinetic energy.
A Philips service engineer will contact impacted customers as soon as the Field Action Kit is available to be implemented.
In the interim, users are advised to always ensure the correct positioning of the hook and that it is locked in accordance with the Instructions for Use (press hook down until it is locked).
This action has been closed out on 06/08/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |