- What is the reason for the recall/withdrawal/field correction?
Sonosite discovered a data (ratio) display anomaly that can occur when performing an S/D (systolic/diastolic) ratio calculation. When performing the calculation, when the systolic and diastolic calipers are initially set, the S/D ratio that is displayed on the screen is correct. However, if the systolic cursor is subsequently moved, the ratio displayed on the screen is not updated to reflect the new value. - What products are affected? How do I identify if I have the affected product?
The issue affects Sonosite MicroMaxx and M-Turbo ultrasound systems enabled with the Extended OB Calculations software package.How to identify if you have a MicroMaxx or M-Turbo:
There is a product label on the bottom side of the system. It will say either “MicroMaxx” or “M-Turbo”How to identify if you have the Extended OB Calculations package
To verify the extended OB/GYN Calculations (EOBC) is enabled on the system:- Press the Setup Button.
- Select System Information from the page list.
- Verify EOBC is an enabled option in the Modes list.
- Are any other products affected?
No, the MicroMaxx and M-Turbo platforms are the only ones that exhibit this anomaly.
- What is wrong with the product?
Sonosite discovered a data (ratio) display anomaly that can occur when performing an S/D (systolic/diastolic) ratio calculation. When performing the calculation, when the systolic and diastolic calipers are initially set, the S/D ratio that is displayed on the screen is correct. However, if the systolic cursor is subsequently moved, the ratio displayed on the screen is not updated to reflect the new value.
- Have there been any injuries related to using this product?
There have been no reported injuries, adverse health outcomes, complaints, or MDR/User Facility reports as a result of this issue since the software was introduced in 2007.
- If my product has the defect, what would I see or experience?
When performing an S/D ratio calculation, if you move the systolic caliper after setting the diastolic caliper, you would notice that the S/D ratio displayed on the screen didn’t update to reflect the new value.
- Can I continue to use the product?
Yes, however when performing an S/D ratio calculation, we recommend that instead of repositioning the systolic caliper (if needed), you retake the measurement, re-placing both the systolic and diastolic calipers.
- What actions are being taken to address the issue?
The Engineering Team at Sonosite has released a software upgrade that will resolve this issue. The free upgrade will be sent to customers with instructions on how to obtain their license key. Please fill out our web form to request an upgrade.
- When can I expect my upgrade?
Your free upgrade kit will be sent within 10-12 weeks
- Who can I speak to if I have further questions?
Please contact Patricia Liau in Regulatory Affairs
Ph: 1.877.590.4928, Select Option 2
Email: regulatory@sonosite.com
Please provide your Serial Number and Contact Information with any phone or email correspondence.
- If I am experiencing a problem with the product, who can I speak to directly about the issue?
Sonosite Technical Support
Email: service@sonosite.com
Ph: 1.877.657.8118, Monday-Friday 6:00 a.m. – 5:00 p.m. (PST)
