Recall Z-1934-2025— Philips North America

Name: FDA recall Z-1934-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-29

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2025-05-29. It names one FDA 510(k) clearance: K193215. Product: Intera 1.5T Omni/Stellar; Product Number: 781104;. Reason: identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2025-05-29
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

Intera 1.5T Omni/Stellar; Product Number: 781104;

Reason for recall

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

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