| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00353-1 |
| Product Name/Description |
Acuson SC200 ultrasound systems
Affected Serial Numbers: 400300 and below
Catalogue Number: 10433816
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Due to an alignment issue with the bezel on the front panel, the plastic cover around the transducer ports prevents full contact of the connector on the transducer to the transducer port on the system. This issue causes the system to lock up.
This may result in a delay in diagnosis while an alternative exam is performed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that in the event a transesophageal transducer is inserted in a patient, the user should first disconnect and reconnect the transducer. If the system still locks up, the user should then follow the instructions on the screen and disconnect the transducer, remove the transducer from the patient, and contact a Siemens service representative. Siemens will be replacing the front panel of the system as a permanent fix. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |