FDA recall Z-0194-2018

Product

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.

Distribution

Nationwide and Canada

Key facts

Status

Terminated

Initiation date

2017-10-05

Report date

2018-03-28

Termination date

2021-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0194-2018