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Philips North America Llc Recall: Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Reso

Philips North America Llc Recall: Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Reso is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips North America Llc; Product: Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indic

Recalling firmPhilips North America Llc
ProductIngenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
Reason for recallPhilips 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide - 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.
Recall initiated20240422
Recall numberZ-1829-2024
Categorydevice
StateMA
CountryUnited States

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