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MRXPERION MR INJECTION SYSTEM (2016-06-06)
- Starting date:
- June 6, 2016
- Posting date:
- June 30, 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-59106
Affected products
A. MRXPERION MR INJECTION SYSTEM
Reason
Complaints were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. An investigation showed that the MRXperion Injector was susceptible to electromagnetic interference when exposed to radio frequency (rf) energy generated during certain sequences on 3T scanners.
Affected products
A. MRXPERION MR INJECTION SYSTEM
Lot or serial number
100085
100104
100166
Model or catalog number
MRXP 200
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES