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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 Recall
Lockheed Martin Gyrocam Systems ( LMGS
see related information
Date Posted February 14, 2013
Recall Status1 Open
Recall Number Z-0654-2013
Recall Event ID 64029
Product Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems Laser pointer and illuminator used for law enforcement surveillance from aircraft.
Code Information Models DNV TS and DS
Recalling Firm/
Manufacturer
Lockheed Martin Gyrocam Systems, Inc.
7345 16th St E Bldg C-101
Manatee County
Sarasota, Florida 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: Radiation Control for Health and Safety Act
Action Please 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 Commerce 33 units
Distribution Nationwide Distribution

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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