| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00595-1 |
| Product Name/Description |
OmniDiagnost-Eleva and OmniDiagnost-Classic
System Codes: 708026, 708027, 708028, 20859, 708023, 708024, 708025
ARTG Number: 98560
(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, general-purpose, stationary, digital) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has received reported instances in which the table of the OmniDiagnost system (OD-Eleva) suddenly started to rotate from 0 to 90 degrees (table arm down) with high speed. The cause of this unexpected rotation movement is related to an issue with the fixation of the upper and lower tilt actuator. This rotating movement cannot be stopped by the user.
If the system rotates uncontrolled, there is a risk of injury for the patient on the table. A rotating table also might hit a user or bystander standing near the system. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising they will be in contact with users to replace affected components on the upper and lower tilt actuator in the impacted systems. It is expected that this action will commence July 2018.
In the interim, users should monitor the tables for any of the following, stop use of, and contact Philips immediately if they occur:
- the table height or tilt movement is not working;
- a cracking or snapping sound is heard during system operation;
- a blockade is experienced in the table height or tilt movement during system movements;
- the system is having an unexpected collision or the system had an unexpected collision in the past 2 months;
- a CPR stand that obstructed the system when in use,; or
- any (other) unusual system behaviour beyond the normal use of the system.
This action has been closed out on 01/08/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |