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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 Siemens Ltd
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