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Monteris Medical Corp recalls MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Recalled March 28, 2018 · FDA recall Z-0194-2018 · Monteris Medical
Hazard
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. · FDA Class I
Units
52 systems
Sold at
Nationwide and Canada
Description
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Product
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Manufacturer(s)
Monteris Medical Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →