07
Jul
2011

Lockheed Martin Aculight Capella-r 1850 LaserCl ll

0

Company:Lockheed-Martin Aculight
Date of Enforcement Report 7/6/2011
Class ll:

PRODUCT
Lockheed Martin Aculight Capella-r 1850 Laser. The Capella Laser is intended for use in user-defined scientific applications and non-human-use research on infrared nerve stimulation. Recall # Z-2069-2011

REASON
It has been determined that there are certain software driven operating sequences involving off-on cycling of the key-switch that do not result in a reset of the Stim Enable button, and emissions can resume after a standard 5 second countdown without pressing this button a second time.

RECALLING FIRM/MANUFACTURER
Lockheed-Martin Aculight, Bothell, WA, by letter on November 19, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17 units

DISTRIBUTION
Nationwide

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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