FDA-Device2014-10-22Class II

Philips Expression MR200 MRI Patient Monitoring System

Invivo Corporation
Hazard

Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.

Sold states
Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.
Affected count
24 units.
Manufactured in
12151 Research Pkwy, Suite 200, Orlando, FL, United States
Products
Philips Expression MR200 MRI Patient Monitoring System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2015

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