Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Cla

FDA device recall Z-2069-2011 · posted 2011-05-19 · Terminated

Recall details

Recalling firm

Lockheed-Martin Aculight

Reason for recall

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.

Action taken

On 11/22/10, Lockheed Martin Aculight sent a Memo to their Customers and Users informing them of the "Stim Enable" button reset error. The defect involves the function of the "Stim Enable" button on the front panel of the Capella R-1850. In December 2010, the firm sent a second lletter with instructions on how to return the Capella R-1850 Laser back for repair. The firm's plan to correct the defect involved removal of existing software, installation of revised software, and documented verification testing, per written instructions, to confirm resolution of the Stim-Emit button failure to reset. Corrections were to be made at no cost to the customer. A Lockheed Martin Aculight customer service representative will contact you shortly and provide detailed information on how to return the Capella-R 1850 laser product in your possession for testing and repair on this defect. Should you have any questions, please call (425) 482-1100.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

RGB

Quantity affected

17 units

Distribution

Devices were distributed Universities, Institute, and government consignees in CT, IL, MA, MD, OH, TN, TX, and UT. One unit was distributed to Germany.

Date initiated

2010-11-19

Date posted

2011-05-19

Date terminated

2011-08-23

Location

Bothell, WA