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Monteris Medical NeuroBlate system (2017-10-05)
- Starting date:
- October 5, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-65056
Affected products
Monteris Medical NeuroBlate system
Reason
After reports of probe damage during four procedures, the investigation concluded a 1.5 MRI system interacted with the NeuroBlate probe such that radiofrequency (rf) energy was transferred to the probe, resulting in unintended heating and damage at the tip of the probe.
Affected products
Monteris Medical NeuroBlate system
Lot or serial number
All lots
Model or catalog number
NB102
NB102-R
NB102-XX
NB102-XX-R
Companies
- Manufacturer
-
MONTERIS MEDICAL CORPORATION
14755 27TH AVE NORTH, SUITE C
PLYMOUTH
55447
Minnesota
UNITED STATES