Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-00849-1 |
Product Name/Description |
MX 16-Slice (Full body CT system)
All systems affected
ARTG Number: 98868 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
12/08/2013 |
Responsible Entity |
|
Reason/Issue |
Philips Healthcare received a report stating that a doctor received a finger pinch from the table top, which resulted in injury. The injury occurred when the doctor placed their hand at the end of the table top. The operator of the system did not notice that the doctor's finger was positioned at the pinch point when they started the movement of the table top. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Philips will be providing additional warning labels and instructions to users to prevent this issue from occurring. In the interim, Philips Healthcare is advising users to ensure CT scanner room access is controlled by procedures and policies that identify authorised personnel, and includes that patient or bystanders are to keep hands away from the table top when moving. Philips is advising operators to observe the status of patient or bystander when operating the control panel and CT-Box to control patient table. |
Contact Information |
1800 251 400 - Philips Customer Care Centre |