Recall Z-1829-2024— Philips North America Llc

Name: FDA recall Z-1829-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-22

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2024-04-22. It names one FDA 510(k) clearance: K193215. 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: 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.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2024-04-22
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193215 — Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.·cleared 2020-04-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.