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MRXPERION MR INJECTION SYSTEM(2015-08-19)
- Starting date:
- August 19, 2015
- Posting date:
- October 8, 2015
- 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-55276
Affected Products
MRXPERION MR INJECTION SYSTEM
Reason
It was identified that during an injection there is a potential that a saline phase could not be completed, if the injection is started or resumed while a keep vein open (KVO) pulse is active. Additionally, a software revision will be implemented to adjust the reminder behavior to ensure that if the injection phase is paused manually, the reminder timer resumes once the injection phase is resumed.
Affected products
MRXPERION MR INJECTION SYSTEM
Lot or serial number
Serial number 100029
Model or catalog number
MRXP 200
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES