Z-2069-2011

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

Name: Z-2069-2011 Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella...
Creator: Lockheed-Martin Aculight
Published: 2010-11-19
License: https://open.fda.gov/license/

Lockheed-Martin Aculight / initiated 2010-11-19 / Terminated / root cause: software

FDA source

Lockheed-Martin Aculight began a recall of Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Class 4 solid state diode laser product... on 2010-11-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2069-2011
Status: Terminated
Initiated: 2010-11-19
Posted: 2011-05-19
Terminated: 2011-08-23
Recalling firm: Lockheed-Martin Aculight
Product: Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The Capella R-1850 is a Class 4 solid state diode laser product designed to emit 1850mn laser radiation at maximum pulse energy of 5 mJ (@1ms). The output port connects to a user-selected 200-600 micron diameter optical fiber. The Capella R-1850 is labeled in part: "***LASER APERTURE***Aculight Corporation 22121 20th ave SE Bothell, WA 98021***Feb 2007***Model R-1850, SN: 007***".
Product code: RGB Veterinary Laser
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.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 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.
Product codes and lots: SERIAL NUMBERS: 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 107, 1031, 1032, 1041, 1065, and 1071.

Product code RGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)