FDA Device recall Z-2419-2021

Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device

• FDA Device
• Class II
• completed
• Published 2021-09-15

On 2021-09-15 the FDA classified a Class II recall of Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device by Philips North America, citing when using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment.

Read the official FDA Device notice

Product

Ingenia Elition X-a 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 Models: 781358

Reason

When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment

Identifiers

Status history

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

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2419-2021%22

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