| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01328-1 |
| Product Name/Description |
Essenta DR X-ray System (Digital diagnostic X-Ray system)
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
If during system installation, the screws holding the C-arm were mounted using thread locking compound (for example, LOCTITE), then the corresponding thread inserts inside the C-arm casting may loosen when the C-arm is dismantled. If after reassembly of the system, the loosened thread inserts become detached from the casting, the C-arm would no longer securely held in position and could fall. The C-arm is most often dismantled and reassembled when the system is moved to another location. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising users to check the connection of the C-arm to the column to ensure the C-arm is parallel to the column in side view. If the C-arm is not parallel, do not use the system and contact Philips Healthcare. Philips Healthcare is inspecting all affected units and applying a safety label on affected systems. Local service manuals will be updated at each system site. |
| Contact Information |
1800 251 400 - Phillips Customer Care Centre |