FDA recall Z-1829-2024

Philips North America Llc · Class II · device

Product

Ingenia 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 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.

Key facts

Status
Ongoing
Initiation date
2024-04-22
Report date
2024-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1829-2024