Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29219 |
| Brand Name: | Acuson Ultrasound System |
| Model: | 11289564 |
| Affected: | BT10672, BT10582, BT10617, BT10643, BT10669, BT10580, BT10619, BT10659, BT10611, BT10612, BT10614, BT10673, BT10581, BT10494, BT10610, BT10641, BT10497, BT10615, BT10661, BT10667, BT00248, BT10613, BT10657, BT10640, BT10584, BT10488, BT10481, BT10644. |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Medical Solutions USA Inc |
| Issue: | the manufacturer has identified that a limited number of ACUSON 9VE4 transducers were shipped to customers that did not follow the Acoustic Output Power (AOP) testing process. The potential health risk is that the tissue heating at maximum power output could exceed the stated levels in the user documentation. Excessive heat transfer could create discomfort, cause tissue damage, or have an adverse impact on fetal development at the early stages of pregnancy. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/4/2022 |
