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Neuro II SE Intra-Operative MRI System (2016-02-10)
- Starting date:
- February 10, 2016
- Posting date:
- June 24, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59036
Affected products
A. Neuro II SE Intra-Operative MRI System
Reason
Manufacture has reported discovering quench lines installed by the system owner, which do not meet the specifications provided. If the quench line is not installed properly or is restricted or obstructed, when a quench occurs, it could cause helium gas to vent directly into the MRI room or other areas.
Affected products
A. Neuro II SE Intra-Operative MRI System
Lot or serial number
- 40263
- 40475
- 40619
- M00106
Model or catalog number
NEURO II-SE
Companies
- Manufacturer
-
DEERFIELD IMAGING, INC
5101 SHADY OAK ROAD,
MINNETONKA
55343
Minnesota
UNITED STATES