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MRXPERION MR INJECTION SYSTEM (2016-06-24)
- Starting date:
- June 24, 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-58830
Affected products
A. MRXPERION MR INJECTION SYSTEM
Reason
In October 2015, a customer complaint was received where it was reported that during a procedure, a false button push occurred while the MRXperion injector was being used with a Siemens Skyra 3T scanner. It was found that the head user interface assembly was non-conforming due to inadequate/missing shielding applied to the graphic overlay layer of the laminated assembly manufactured by the supplier.
Affected products
A. MRXPERION MR INJECTION SYSTEM
Lot or serial number
Serial Number 100054
Model or catalog number
MRXP 200
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES