Events

Recall of Device Recall Lockheed Martin Aculight Capella R1850 Laser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lockheed-Martin Aculight.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57473
  • Event Risk Class
    Class 2
  • Event Number
    Z-2069-2011
  • Event Initiated Date
    2010-11-19
  • Event Date Posted
    2011-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96310
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Veterinary laser - Product Code RGB
  • 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.
  • 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.

Device

Device Recall Lockheed Martin Aculight Capella R1850 Laser
  • Model / Serial
    SERIAL NUMBERS: 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 107, 1031, 1032, 1041, 1065, and 1071.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • 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 Description
    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***".
  • Manufacturer
    Lockheed-Martin Aculight

Manufacturer

Lockheed-Martin Aculight
  • Manufacturer Address
    Lockheed-Martin Aculight, 22121-20th Ave SE, Bothell WA 98021
  • Manufacturer Parent Company (2017)
    Lockheed Martin Corporation
  • Source
    USFDA