Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Lockheed Martin Aculight Capella R1850 Laser

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Lockheed Martin Aculight Capella R1850 Laser see related information
Date Initiated by Firm November 19, 2010
Date Posted May 19, 2011
Recall Status1 Terminated 3 on August 23, 2011
Recall Number Z-2069-2011
Recall Event ID 57473
Product Classification Veterinary laser - Product Code RGB
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***".
Code Information SERIAL NUMBERS: 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 107, 1031, 1032, 1041, 1065, and 1071.
Recalling Firm/
Manufacturer		 Lockheed-Martin Aculight
22121-20th Ave SE
Bothell WA 98021
For Additional Information Contact
425-482-1100
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-