| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00208-1 |
| Product Name/Description |
Kenex ceiling-suspended radiation shields and surgical lamps
ARTG number: 136957 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
This action is an update of the product correction - RC-2014-RN-00407-1 |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is inspecting all affected systems to verify that the Kenex suspension radiation shields and surgical lamps are properly installed. A GE representative will contact customers to arrange for the inspection. Any affected systems will be corrected. This actio has been closed-out on 03/08/2016. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |