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MRIDIUM MRI Infusion System - Pump
- Starting date:
- November 18, 2016
- Posting date:
- December 5, 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-61298
Reason
Change to 1 (one) page on an instruction card set that attaches to the 3860 units. IRadimed Corp continues to investigate reports of possible fluid free flow, and concluded that stretching or improper placement of the IV set during pump set up is the primary cause of these reports. In 2012, IRadimed customers received an updated quick reference instruction card which emphasized proper placement of IV set during pump set up. Since that time, newer customers did not receive this updated quick reference instruction card. Though no incidences of injury have occured, IRadimed is proactively re-issuing this notice to assure the continued safe use of MRidium MR Infusion Pump Systems.
Affected products
MRIDIUM MRI Infusion System - Pump
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
3860
Companies
- Manufacturer
-
Iradimed Corporation
1025 Willa Springs Dr.
Winter Springs
32708
Florida
UNITED STATES