FDA-Device2018-03-28Class I
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Monteris Medical Corp
Hazard
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Sold states
Nationwide and Canada
Affected count
52 systems
Manufactured in
14755 27th Ave N Ste C, N/A, Plymouth, MN, United States
Products
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0194-2018Don't want to check this manually?
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