Company: SonoSite.
Date of Enforcement Report 12/22/2010
Class lll:

PRODUCT
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. Part code: P11111-35. Recall # Z-0478-2011

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.

RECALLING FIRM/MANUFACTURER
Sonosite, Inc., Bothell, WA, by letters dated August 9, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
69

DISTRIBUTION
Nationwide and internationally