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Monteris Medical

4 recalls •
🏥 Medical Devices
• Categories: Surgical Instruments, Diagnostic Equipment, Infusion Pumps

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.

Class I - Dangerous

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.

Mar 25, 2016 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

Oct 3, 2014 Infusion Pumps View Details →

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.

Class I - Dangerous

Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

Oct 3, 2014 Infusion Pumps View Details →