FDA-Device2014-11-26Class II
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.
Monteris Medical Corp
Hazard
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Sold states
US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
Affected count
133 devices
Manufactured in
16305 36th Ave N Suite 200, N/A, Plymouth, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0228-2015Don't want to check this manually?
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