Z-0194-2018 Class I Terminated
FDA device recall Z-0194-2018 was initiated by Monteris Medical Corp on October 5, 2017 and is designated Class I. Reason for recall: The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems. The recall status is terminated (terminated January 21, 2021). Affected quantity: 52 systems.
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