Recall Z-2347-2021— Philips North America Llc

Name: FDA recall Z-2347-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-30

Class II · Terminated

Class II FDA medical device recall by Philips North America Llc, initiated 2021-07-30, terminated 2023-07-25. It names one FDA 510(k) clearance: K173451. Product: Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS). Reason: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury.

Recalling firm: Philips North America Llc
Classification: Class II
Status: Terminated
Initiated: 2021-07-30
Terminated: 2023-07-25
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K173451 — Ingenia Elition S and Ingenia Elition XPhilips Medical Systems Nederland B.V.·cleared 2018-03-20

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 Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781357 (OUS)

Reason for recall

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

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