FDAFDA · Alimentos y medicamentos·N.º oficial Z-0654-2013
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
Publicado el 20 de febrero de 2013 · Inicio del retiro: 21 de enero de 2010
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Lockheed Martin Gyrocam Systems, Inc.
- Distribuidor
- Nationwide Distribution
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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