Monteris Medical Corp - NeuroBiate System SideFireTM Select 2.2 mm Directional Laser Probe - Class 1 Recall

NeuroBiate¿ System SideFireTM Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01,SFS122-01, SFS222-01, SFS322-01, SFS422-01, SFS522-01. NeuroBiate System SideFire TM Select Directional Laser Probes are part of the NeuroBiate System. The cleared indications for the NeuroBiate System are as follows: The Monteris Medical NeuroBiate¿ 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 NeuroBiate¿ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBiate¿ Laser Delivery Probe. It also provides real-time thermographic analysis of selected MRI images. When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBiate TM analysis. The laser delivery probes direct the laser energy to the proper treatment location.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts