| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00325-1 |
| Product Name/Description |
ACUSON SC2000 System (Ultrasound cardiovascular imaging system) when used with V5M Transducer (which includes revision 4 of the MPI board)
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be lower than the actual temperature of the V5M transducer. This occurs only if the system hardware contains revision 4 of the MPI board. If this condition occurs when scanning a febrile or hyperthermic patient using maximum system power settings (0 db), the actual lens surface temperature could exceed 43degC while the system temperature display continues to show a value under 43degC. There is a potential to cause oesophageal burns in patients with body temperatures greater than 40degC.
Products supplied in Australia include a different transducer (4Z1c) which cannot be used for trans-oesophageal imaging. Potential for heating with this model is mitigated by independent mechanical cooling which is not dependent on a feedback mechanism. Siemens is correcting all models including revision 4 of the MPI board irrespective of the transducer version. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing temporary work around instructions and is implementing an upgrade of the system hardware that will correct the issue. |
| Contact Information |
1800 310 300 - Siemens Technical Assistance |