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U.S. Department of Health and Human Services

Class 2 Device Recall Lockheed Martin Gyrocam Systems ( LMGS

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 Class 2 Device Recall Lockheed Martin Gyrocam Systems ( LMGSsee related information
Date Initiated by FirmJanuary 21, 2010
Date PostedFebruary 14, 2013
Recall Status1 Terminated 3 on February 24, 2015
Recall NumberZ-0654-2013
Recall Event ID 64029
Product Classification Ir laser illuminator only/night vision system - Product Code REX
ProductLockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
Code Information Gyrocam DNV Camera System, Serial Numbers: 137, 138, 141, 142, 143, 144, 145, 148, 150, 151, 152, 158, 159, 160, 164, 165, 170, 172, 173, 174, 175, 177; Gyrocam DS Camera System, Serial Numbers: 134, 140, 147, 153, 169, 181; Gyrocam TS Camera System, Serial Numbers: 132, 146, 149, 171, 502. 
FEI Number 3004882148
Recalling Firm/
Manufacturer		 Lockheed Martin Gyrocam Systems, Inc.
7345 16th St E Bldg C-101
Manatee County
Sarasota FL 34243-6808
Manufacturer Reason
for Recall		These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. These camera systems incorporate Class IIIb surveying, leveling, and alignment lasers and were entered into US commerce without a variance. Additionally, the manufacturer did not submit a product report to FDA for the camera system.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionPlease note that LMGS is responsible for the correction of all noncompliant products. 1. Notifications to all purchasers must be made, and the FDA district office Recall Coordinator is to be included in the notifications. 2. Correction of all units to be completed by November 8, 2013. 3. All products will be brought into compliance with the laser performance standard at no cost to the purchaser. 4. LMGS will submit a product report for the new camera system prior to installation of the replacement lasers as per 21 CFR 1002.10 and certify that the new camera systems comply with the general performance standard in 21 CFR 1010 and the laser performance standard found in 21 CFR 1040.10 and 1040.11 5. Updated operator manuals will be provided to purchasers. Further questions please call (941) 355-3206.
Quantity in Commerce33 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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.
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