| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00478-1 |
| Product Name/Description |
ACUSON S Family ultrasound systems with software versions VD10A or VD10C when using 18L6 HD transducer
Catalogue Numbers:
S1000 – 10441701
S2000 – 10041461
S2000 (Refurbished) – 10440017
S3000 – 10441730
18L6 HD Transducer - 10041227 & 10789400
ARTG Number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified a potential issue with the 18L6 HD transducer on the ACUSON S Family ultrasound systems (with software versions VD10A or VD10). When scanning with the 18L6 transducer on the ACUSON HELX Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. When the triple image issue occurs, the system repeats one-third of the aperture, but does not display the full field of view. The issue occurs intermittently when connecting the 18L6 HD transducer to the ultrasound system or when selecting the touch screen control to activate the transducer. The potential risk is specific to breast exams and the possibility of not visualising lesions when acquiring images of breast tissue, which may result in a misdiagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is recommending users perform the following steps before using the18L6 HD transducer: Connect the transducer to the ultrasound system and place a gel-coated fingertip on the transducer face. Drag the finger along the entire face of the transducer and if the echo from the finger displays in triplicate, disconnect and reconnect the transducer. Then repeat the test. It is recommended that users review any breast studies performed with an affected device to confirm no triple images were used as part of a diagnosis. Siemens is advising users that steps have been taken to resolve the issue with a software release.
This action has been closed out on 11/10/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |