Medical Device Recall: 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 · April 22, 2024
Reason for Recall
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
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
19 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1830-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.