| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00241-1 |
| Product Name/Description |
ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cable
Catalogue number: 10433816
ARTG Number: 139591
Siemens Healthcare - Ultrasound system, imaging, cardiovascular |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has identified that in some cases the ECG signal may flatline due to electromagnetic interference when used in conjunction with electrosurgical equipment. The electrosurgical equipment creates electromagnetic interference (EMI) which is then transmitted to the physio module and the SC2000 system through the AUX IN/OUT cable. This interference causes the system to lose communication with the physio module.
To date, there have been no reported injuries as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Siemens is advising:
If the ECG trace disappears or flatlines, perform the following steps to disable the ECG trace and exit the physio module functionality:
1. Press F13 (Physio) on the keyboard.
2. Press the scroll wheel to select the appropriate ECG or AUX trace option and then press the Off soft key.
3. To exit the Physio menu, press F13 (Physio) again.
After these steps are performed, the ultrasound system will use time-based captures instead of beat captures.
Also note that the system may be rebooted to reset the ECG trace. However, if the electrosurgery equipment is used again the symptom will reoccur.
This issue will be resolved by a hardware update to affected systems. Siemens Customer Service will contact users to schedule this replacement if the system configuration is affected by the scope of this issue.
This action has been closed out on 06/02/2019 |
| Contact Information |
1800 310 300 - Customer Care Centre |