Recall Z-0194-2018— Monteris Medical Corp

Name: FDA recall Z-0194-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-05

Class I · Terminated

Class I FDA medical device recall by Monteris Medical Corp, initiated 2017-10-05, terminated 2021-01-21. It names one FDA 510(k) clearance: K171255. Product: MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.. Reason: The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems..

Recalling firm: Monteris Medical Corp
Classification: Class I
Status: Terminated
Initiated: 2017-10-05
Terminated: 2021-01-21
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K171255 — Monteris Medical NeuroBlate SystemMonteris Medical, Inc.·cleared 2017-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.

Reason for recall

The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.

Data sourced from openFDA. This site is unofficial and independent of the FDA.