FDAFDA · Alimentos y medicamentos·N.º oficial Z-0228-2015
FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.
Publicado el 26 de noviembre de 2014 · Inicio del retiro: 3 de octubre de 2014
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
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Monteris Medical Corp
- Distribuidor
- US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
- Lote
- serial numbers: 20414-1-C1274-03, 20414-1-C1274-04, 20414-1-C1274-06, 20414-1-C1274-07, 20414-1-C1274-08, 20414-1-C1274-09, 20414-1-C1274-11, 20414-1-C1274-12, 20414-1-C1274-13, 20414-1-C1274-17, 20414-1-C1274-19, 20414-1-C1274-20, 20414-1-C1367-01, 20414-1-C1367-02, 20414-1-C1367-04, 20414-1-C1367-05, 20414-1-C1367-06, 20414-1-C1367-07, 20414-1-C3302-02, 20414-1-C3302-05, 20414-1-C3302-08, 20414-1-C3302-10, 20414-1-C3302-12, 20414-1-C3302-13, 20414-1-C3302-14, 20414-1-C3302-15, 20414-1-C3302-16, 20414-1-C3302-17, 20414-1-C3502-01, 20414-1-C3502-02, 20414-1-C3502-03, 20414-1-C3502-05, 20414-1-C3502-06, 20414-1-C3502-07, 20414-1-C3502-08, 20414-1-C3502-09, 20414-1-C3502-10, 20414-1-C3502-11, 20414-1-C3502-12, 20414-1-C3502-13, 20414-1-C3502-14, 20414-1-C3502-15, 20414-1-C3502-16, 20414-1-C3502-17, 20414-2-C1275-01, 20414-2-C1275-02, 20414-2-C1275-03, 20414-2-C1275-04, 20414-2-C1275-05, 20414-2-C1275-06, 20414-2-C1275-07, 20414-2-C1275-08, 20414-2-C1275-09, 20414-2-C1275-11, 20414-2-C1275-12, 20414-2-C1275-13, 20414-2-C1275-15, 20414-2-C1275-16, 20414-2-C1275-17, 20414-2-C1275-18, 20414-2-C1275-19, 20414-2-C1275-20, 20414-2-C1404-01, 20414-2-C1404-02, 20414-2-C1404-03, 20414-2-C1404-04, 20414-2-C1404-06, 20414-2-C1404-07, 20414-2-C1404-08, 20414-2-C1431-08, 20414-3-C1277-01, 20414-3-C1277-02, 20414-3-C1277-03, 20414-3-C1277-04, 20414-3-C1277-05, 20414-3-C1277-06, 20414-3-C1277-07, 20414-3-C1277-08, 20414-3-C1277-09, 20414-3-C1277-10, 20414-3-C3154-01, 20414-3-C3154-02, 20414-3-C3154-03, 20414-3-C3154-04, 20414-3-C3154-05, 20414-3-C3154-06, 20414-3-C3154-08, 20414-3-C3154-09, 20414-3-C3154-10, 20414-3-C3154-11, 20414-3-C3154-12, 20414-3-C3154-13, 20414-3-C3154-14, 20414-3-C3154-15, 20414-3-C3154-16, 20414-3-C3154-17, 20414-3-C3154-18, 20414-3-C3154-19, 20414-3-C3309-01, 20414-3-C3309-03, 20414-3-C3309-05, 20414-3-C3442-01, 20414-3-C3442-02, 20414-4-C1278-01, 20414-4-C1278-02, 20414-4-C1278-03, 20414-4-C1278-04, 20414-4-C1278-05, 20414-4-C1278-06, 20414-4-C1278-07, 20414-4-C1278-08, 20414-4-C1278-09, 20414-4-C1278-10, 20414-4-C1278-11, 20414-4-C1278-12, 20414-4-C1278-13, 20414-4-C3315-01, 20414-4-C3315-04, 20414-4-C3315-05, 20414-4-C3315-06, 20414-4-C3315-07, 20414-4-C3315-08, 20414-4-C3315-09, 20414-4-C3433-01, 20414-4-C3433-02, 20414-4-C3433-03, 20414-4-C3433-04, 20414-4-C3433-05, 20414-5-C1279-10, 20414-5-C1279-14, 20414-5-C1279-15, 20414-5-C3322-01, 20414-5-C3322-02.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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