FDA-Device2014-06-11Class II
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
Bayer Corp
Hazard
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.
Sold states
Worldwide Distribution - USA (nationwide) including the countries of Australia, Brazil, Belgium, Canada, Germany, Singapore, South Africa, Poland, Mexico and UAE.
Affected count
1347
Manufactured in
100 Global View Dr, Warrendale, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1673-2014Don't want to check this manually?
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