| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00420-1 |
| Product Name/Description |
ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00 or 1.1.02
Catalogue/Lot number – 1065844
ARTG number: 137563 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
When fourSight 4D ultrasound imaging, 3-Scape real-time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology studies, the following data from the previous patient could replace the current patient's data in the report:
- Clinical LMP (Last Menstrual Period)
- Clinical EDC (Estimated Date of Confinement)
- Clinical MA (Menstrual Age)
- Indication
If the replaced data is not noticed, there is a potential risk of performing additional diagnostic or non-indicated therapeutic procedures. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To avoid this scenario, the following steps are recommended by Siemens:
- Always review the patient report at the end of each study and confirm the report contains only measurements and patient data relevant to the exam just performed.
- Before exiting fourSight 4D ultrasound imaging or 3-Scape (3D) imaging access and review the patient report. This step refreshes the data in the report.
A new version of software resolving the error will be implemented in the affected units. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |