Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Recall Z-1673-2014 · Posted 2014-05-30
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Reason for Recall
Firm Action
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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