FDA Device recall Z-2343-2021

Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device

• FDA Device
• Class II
• terminated
• Published 2021-09-01

On 2021-09-01 the FDA classified a Class II recall of Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device by Philips North America, citing 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.

Read the official FDA Device notice

Product

Ingenia 3.0T-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: 781342

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

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2343-2021%22

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