| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00762-1 |
| Product Name/Description |
ACUSON Juniper, ACUSON Maple and ACUSON Redwood Ultrasound systems
Multiple systems, model numbers and software versions.
ARTG 387110
(Siemens Healthcare Pty Ltd - Ultrasound system, imaging, general-purpose) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
The system incorrectly performs a unit conversion of litres to millilitres using a multiplier of 100 (one hundred) instead of using the correct multiplier of 1000 (one thousand) in specific situations. The result of this conversion error is the presentation of a 10x under-estimated measured value.
This unit conversion problem displays an inaccurate value that is 10x smaller than the actual measurement ONLY after a system is changed from the factory default configuration units of measure to display the following:
- Millilitres per second: unit displayed as either ml/sec or mL/sec (ACUSON Juniper, ACUSON Maple and ACUSON Redwood)
- Millilitres per minute: unit displayed as either ml/min or mL/min (ACUSON Redwood)
If undetected and used in isolation, volume flow measurement values that are under-represented by a factor of 10 could contribute to misdiagnosis of a patient's condition or influence patient management decisions in a negative way. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
To avoid potential misdiagnosis by an under-represented volume flow measurement value, customers should use the factory default display configuration of l/min (litres per minute).
Siemens Healthineers recommends a review of previous examination results ONLY if a clinical assessment reviewed a volume flow measurement(s) with the unit of measurement configured to display a value in millilitres.
Siemens Healthineers will correct this problem with a free-of-charge software update to affected systems. Customers will be contacted by Siemens when the software update is available, expected to be in Q4 of 2024. |
| Contact Information |
1800 310 300 - Customer Care Centre |