Monteris Medical Corp: Medical Device Recall in 2018 - (Recall #: Z-0194-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: October 5, 2017

Date Posted: March 28, 2018

Recall Number: Z-0194-2018

Event ID: 78315

Reason for Recall:

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

Status: Terminated

Product Quantity: 52 systems

Code Information:

All serial numbers

Distribution Pattern:

Nationwide and Canada

Voluntary or Mandated:

Voluntary: Firm initiated