Recall Z-0394-2024— Philips North America Llc

Name: FDA recall Z-0394-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-23

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-10-23. It names one FDA 510(k) clearance: K162931. Product: Intera 1.5T Power/Pulsar. Reason: Potential component failure in the Gradient Coil could product smoke and/or fire..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-10-23
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162931 — Ingenia 1.5T CX and Ingenia 3.0T CX R5.3Philips Medical Systems Nederland B.V.·cleared 2017-01-06

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 Power/Pulsar

Reason for recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

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