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Monteris Medical Corp recalls SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are p
Recalled November 26, 2014 · FDA recall Z-0227-2015 · Monteris Medical
Hazard
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. · FDA Class II
Units
234 devices
Sold at
US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
Description
Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Product
SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. 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.
Manufacturer(s)
Monteris Medical Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →