22
Dec
2010

Cl lll SonoSite NanoMaxx ultrasound system

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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