| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00005-1 |
| Product Name/Description |
ACUSON SC2000 Ultrasound Systems
Catalogue Number: 10433816
Serial Numbers lower than 401100
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism., The swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. If the connection of the user interface module to the column on the ultrasound system is lose, the entire module may fall off the ultrasound system. There is a potential risk of striking and harming anyone in the environment of the ultrasound system. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. If looseness is observed, discontinue use immediately and contact a Siemens service representative. A service engineer will perform the necessary repairs. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |