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Terminated

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.

FDA Recall Z-0478-2011 · Posted 2010-11-26

Recalling FirmSonosite, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2010-08-13
Date Terminated2011-07-21
Product Quantity69

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMSonosite,Inc. · 2009-10-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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