FDA-Device2024-05-22Class II
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Philips North America Llc
Hazard
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Sold states
Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.
Affected count
19 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782117
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1830-2024Don't want to check this manually?
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