Recall Z-0478-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Sonosite, Inc.
The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.
| Date | Nov 26, 2010 (initiated Aug 13, 2010) |
| Status | Terminated |
| Reason | Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect. |
| Root cause | Software design |
| Action | Sonosite issued Urgent Medical Device Correction letters dated August 9, 2010 to consignees. Consignees were advised of the software problem and given directions to verify the software version they are using. They are advised to contact SonoSite at 877-657-8118 to obtain a free software upgrade. |
| Quantity | 69 |
| Distribution | Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM Sonosite,Inc., Oct 2, 2009 |