Monteris Medical Neuroblate System recall
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Why was Monteris Medical Neuroblate System recalled?
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers
- Product
- MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
- Recalling firm
- Monteris Medical Corp
- Quantity
- 52 systems
- Distribution
- Nationwide and Canada
- Recall date
- March 28, 2018
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)