| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00735-1 |
| Product Name/Description |
Philips Trauma Diagnost X-ray Systems
All Trauma Diagnost systems delivered prior to 8th of July 2007 are affected.
ARTG Number: 100344 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
If two of the three fixation bolts of the Trauma supporting block connecting the Trauma arm with the CS telescope arm are cracked out of its thread, the Trauma arm is no longer fastened securely. Subsequently, the 3rd bolt may easily break during normal use and the Trauma arm would fall down. There is a potential that the C-arm could fall down onto the table and impact on the patient or bystander. The following factors are required for this situation to occur:
- Unusual wear and tear (e.g. multiple collisions)
- There is more than one broken fixation screw and the user is unaware
- Operator is in contact with, moves, or operates the Trauma arm
- A person is situated below the Trauma arm |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A Philips Service Engineer will contact affected customers as soon as the Field Action Kit is ready to be implemented. Philips is recommending the customers not to position the ceiling suspension with the Trauma arm directly above a patient until Philips Service Engineer repairs the affected systems. This action has been closed-out on 06/09/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |