Events

Retiro De Equipo (Recall) de Device Recall Lockheed Martin Gyrocam Systems ( LMGS

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Lockheed Martin Gyrocam Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64029
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0654-2013
  • Fecha de inicio del evento
    2010-01-21
  • Fecha de publicación del evento
    2013-02-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115239
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ir laser illuminator only/night vision system - Product Code REX
  • Causa
    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.
  • Acción
    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.

Device

Device Recall Lockheed Martin Gyrocam Systems ( LMGS
  • Modelo / Serial
    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.
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    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
  • Manufacturer
    Lockheed Martin Gyrocam Systems, Inc.

Manufacturer

Lockheed Martin Gyrocam Systems, Inc.
  • Dirección del fabricante
    Lockheed Martin Gyrocam Systems, Inc., 7345 16th St E Bldg C-101, Manatee County, Sarasota FL 34243-6808
  • Source
    USFDA