Home / Recalls / Monteris Medical Corp / Z-0194-2018

Z-0194-2018 Class I Terminated

Recalled by Monteris Medical Corp — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
March 28, 2018
Initiation Date
October 5, 2017
Termination Date
January 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52 systems

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.

Distribution Pattern

Nationwide and Canada

Code Information

All serial numbers

Other recalls by Monteris Medical Corp

  • Z-1614-2016 Class I — NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. M (March 25, 2016)
  • Z-0228-2015 Class II — FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP40 (October 3, 2014)
  • Z-0227-2015 Class II — SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401- (October 3, 2014)