Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-1830-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 22, 2024

Date Posted: May 22, 2024

Recall Number: Z-1830-2024

Event ID: 94493

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

Status: Ongoing

Product Quantity: 19 units

Code Information:

UDI-DI: (01)00884838099739(21) Serial Numbers: 42029 42217 42246 71044 71774 85146 85645 85663 85664 85668 85677 85680 85681 85685 85700 85704 85705 85706 85713

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated