| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01064-1 |
| Product Name/Description |
Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
Catalogue Number: CWKS DISPLAY
Part Number: PN 3030896
Impacted Workstation Serial Numbers start with KSA051
ARTG Number: 170562 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medrad has identified that an internal cable connection in the All-in-One computer component of certain Certegra Workstations used in conjunction with the Medrad Stellant CT Injection System may potentially exhibit thermal events such as smoke, sparks or fire. This is a result of degradation over time of the shielding within the connection. If such an event occurs, a delay of procedure, coughing, nausea, difficulty breathing, or first or second degree burns may occur.
There have been no patient or user injuries reported as a result of this situation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Imaxeon will be arranging for impacted Workstations to be replaced. In the interim, users are advised to take the following actions.
1. While computers are normally warm during use, remain vigilant in checking the back of the Workstation for signs of smoke or other thermal activity while the system is in use. If smoke or other thermal activity is observed, unplug the power cord and discontinue use of your Workstation until it is replaced.
2. Power down the system when you are closing your CT suite for the day or when the CT suite will not be staffed for an extended time and then power it back up prior to your next contrast enhanced CT scan.
Interim Instructions for Use with further details will be provided with the customer letter. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 8845 4999 - Imaxeon Customer Support Team |