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FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for

S4 · ~Oct 2017 · Monteris Medical

Record

CompanyMonteris Medical
IndustryMedical robotics
Type(s)recall
Date~Oct 2017 (month precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (serious injury, total loss, or grounding)
ScaleMONTERIS MEDICAL NEUROBLATE SYSTEM, used for
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class I, recall Z-0194-2018): The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)
DateSupporting source rowPublisherLink
~Oct 2017 FDA Class I recall: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for openFDA enforcement openFDA enforcement

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