Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator us...
FDA Recall #Z-0654-2013 — Class II — January 21, 2010
Product Description
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
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.
Recalling Firm
Lockheed Martin Gyrocam Systems, Inc. — Sarasota, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
33 units
Distribution
Nationwide Distribution
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated