| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00035-1 |
| Product Name/Description |
ACUSON SC2000 ultrasound systems
System material number 10433816 (specific serial number range with component material number 10852376 installed)
ARTG number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal bolt intended to hold the control panel in a fixed position can fail. If this bolt fails, the operator cannot lock the control panel into position, and the steering and rotation of the console will also be affected. The up/down positioning is not affected. Portable exams are not possible and bedside exams are more difficult without these positioning capabilities. There is potential risk for not controlling the system during transport or during a patient examination. Potential harms include bruises, cuts, scrapes, or broken bones. To date no patient injury has been reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Affected customers will be contacted by Siemens to schedule the necessary repairs on site. This action has been closed-out on 03/08/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |