Reported Mar 28, 2018 · Terminated
MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
Monteris Medical Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Monteris Medical Corp · 14755 27th Ave N Ste C · Plymouth, MN · 55447-4866
Is this the product you have?
- MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
- Lot codes and dates
- All serial numbers
- Amount recalled
- 52 systems
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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