FDAFDA · Alimentos y medicamentos·N.º oficial Z-1614-2016
NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01, SFS422-01, and SFS522-01. NeuroBlate System SideFire Select Directional Laser Probes are part of the NeuroBlate System. The Monteris Medical NeuroBlate System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It also provides real-time thermographic analysis of selected MRI images. The laser delivery probes direct the laser energy to the proper treatment location.
Publicado el 25 de mayo de 2016 · Inicio del retiro: 25 de marzo de 2016
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 received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Monteris Medical Corp
- Distribuidor
- Nationwide Distribution in the states of KS, MO, NC, OH, and VA.
- Lote
- All unexpired lots of these models are being removed from the market.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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